FDA-RFP-18-1190619(Amendment-1).pdf

FDA-RFP-18-1190619 (Amendment 1) Vape Inspection Services

PART I

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 SOLICITATION DESCRIPTION

The Contractor shall furnish all necessary facilities, materials, and personnel, and shall perform all non-personal services and program support necessary in a requirement titled, “Vape Inspections”.

This is a combined synopsis/solicitation for commercial items prepared in accordance with 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 solicitation is a Request for Proposals (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-96. The associated North American Industrial Classification System (NAICS) code for this procurement is 541990, All Other Professional, Scientific and Technical Services. Its associated Small Business Size Standard is $15M.

This requirement is for a woman owned small business Set-Aside as a result of this combined synopsis/solicitation.

B.2 CONTRACT TYPE

The government intends to make a single Indefinite-Delivery, Indefinite-Quantity (IDIQ) Contract award with the issuance of Time and Material, Labor Hour and Firm-Fixed (or hybrid) price task orders. The structure of the contract shall be a base period of one (1) year followed by four (4) separate option periods. The total potential period of performance should all four (4) options be awarded is five (5) years.

B.3 CONTRACT CEILING

The IDIQ guaranteed minimum amount will be $5,000.00 over five (5) years inclusive of options. The contract maximum ceiling amount will be $23,000,000.00 over five (5) years inclusive of options.

B.4 PRICING

The pricing chart below outlines all of the labor categories that shall be required throughout the life of the contract. The Contractor shall provide services in accordance with the Statement of Work with fully loaded, fixed hourly rates.

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P295_49268

Labor Rate Pricing Chart:

Labor Category Estimated

Annual Hours

Year 1 Hourly Rates

(Base)

Year 2 Hourly Rates

(Option #1)

Year 3 Hourly Rates

(Option #2)

Year 4 Hourly Rates

(Option #3)

Year 5 Hourly Rates

(Option #4) Program Manager 2,080 $ $ $ $ $

Program Coordinator 21,560 $ $ $ $ $

Inspector 41,600 $ $ $ $ $

Total $ $ $ $ $

Expense Quantity Unit Total

Other Direct Costs 1 Lot $80,000 Travel 1 Lot $1,000,000

Note: Reference Section C.5 for a full description of each labor category.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1 BACKGROUND

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by, among other things, adding a new chapter granting the Food and Drug Administration (FDA) authority to regulate the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Under the Tobacco Control Act, establishments engaged in the retail sale of FDA-regulated tobacco products (“retailers”) are subject to FDA inspections to document compliance with applicable provisions of the FD&C Act and implementing regulations issued by FDA.

C.2 OBJECTIVES

The purpose of this contract is to inspect establishments in which regulated tobacco products are manufactured, processed, packed, or held for introduction into interstate commerce or after such introduction; entities subject to inspection may assemble, prepare, repack, prepare, compounded, label or relabel (“establishments”). FDA will utilize the information and evidence collected during inspections to document compliance with the FD&C Act, and all applicable requirements and to consider and potentially pursue enforcement actions.

If FDA determines that the results of an inspection indicate a violation of any applicable requirements, FDA may use information and evidence obtained during inspections to pursue any of the enforcement actions authorized by the FD&C Act, including, but not limited to, warning letters, civil money penalties, and no-tobacco-sale orders.

C.3 SCOPE OF WORK

Independently and not as an agent of the Government, the Contractor shall furnish all necessary labor, services, supplies, equipment, facilities, and any other personnel or material resources (except as may be expressly set forth in this Contract as furnished by FDA) and otherwise do all things necessary for the performance of the work described herein.

The Contractor shall inspect establishments engaged in the manufacture, assembly, preparation, compounding, processing, packing or repacking, labeling or relabeling, or holding of regulated tobacco products to document compliance with all applicable provisions of the Food, Drug and Cosmetic Act, including but not limited to: Sections 903(a)(1), 903(a)(7)(A), 910, and 911 of the FD&C Act (21 U.S.C. § 387c(a)(1); 21 U.S.C. § 387c(a)(7)(A); 21 U.S.C. § 387j; 21 U.S.C. § 387k) (available at https://www.gpo.gov/fdsys/browse/collectionUScode.action?collectionCode=USCODE).

Establishments subject to inspection under this Contract include entities engaged in retail activities, including but not limited to “vape shops,” where regulated tobacco products may be manufactured, prepared, compounded, or processed within the premises. The Contractor shall inspect all establishments designated on lists provided by FDA.

Scope-Conducting inspections and providing related support services

Task Orders shall encompass services in one or more of the following task areas:

Activity 1- Transition-in

Transition-In services provide an orderly transition from the incumbent contractor to the successor contractor. The successor Contractor shall work toward the Government’s goal of ensuring minimal disruption to the current operational activities.

The Contractor shall provide Transition-In support during the transition period. Upon completion of the transition-in period, the Contractor shall assume full operating accountability and responsibility for all tasks. Specifics related to the transition-in tasks and timeline will be specified at the Task Order level. Representative transition activities under this task area include:

a. Develop a Transition-In Plan to ensure full operating accountability and responsibility for the Task Order;

b. Conduct and coordinate all onboarding activities and obtain and submit all required paperwork, badging, and commissions for all applicable Contractor https://www.gpo.gov/fdsys/browse/collectionUScode.action?collectionCode=USCODE personnel;

c. Participate in Transition‐In meetings and knowledge transfer activities; and

d. Ensure Contractor key personnel are available to work immediately upon

Task Order award.

e. Obtaining from the incumbent contractor or FDA (if no incumbent contractor), whichever is applicable, all current contact information for all inspectors and minors currently employed by the incumbent contractor and any subcontractor(s) and all current contact information for all inspectors and minors who participated in an FDA inspection within the past five years while employed by the incumbent contractor, any subcontractor, or a preceding contractor.

Activity 2 - Program Management

The Contractor shall provide program management services to ensure the quality, timeliness, and accuracy of its work under this Contract and the applicable Task Order/s. Program management also includes budget, schedule, and quality management of each Task Order and all services and deliverables provided thereunder. Representative activities include:

a. Developing, maintaining, and implementing a quality control plan (QCP) for the Task Order. The QCP shall include quality assurance and quality control activities as described below:

• Periodic reviews of deliverables and delivered information (including all inspection results, data, documents, and photos delivered to FDA) by persons different than those preparing or collecting the deliverables or delivered information, and

• Maintenance of QA records detailing the findings of those reviews.

• Accuracy: Work product, deliverables, delivered data (including but not limited to all reports, inspection results, data, documents, and photos delivered to FDA) shall be accurate in presentation and technical content,

• Clarity: Work product, deliverables, and delivered data shall be clear and concise.

• Consistency to Requirements: All services, work product, deliverables, and delivered data must satisfy all requirements of this contract and the applicable Task Order.

• Timeliness: All services, work product, deliverables, and delivered data shall be submitted by the due date specified in this contract and the applicable Task Order,

• Format: All work product and deliverables shall be submitted in formats and media mutually agreed upon prior to submission.

• Mitigation of risks and other performance issues as they arise.

b. Inspection results are submitted into FDA systems electronically by inspectors promptly after completion of an inspection. The Contractor shall review inspection results submitted by inspectors to ensure conformity with quality and acceptability requirements in the contract and task order;

c. Provide monthly program status reports to FDA. The contents and format of monthly program status reports will be specified at the Task Order level, and may encompass some or all of the following types of information:

• Status and progress of tasks

• Cost and schedule variances against agreed-upon baselines;

• Significant risks to scheduled deliverables and plans to mitigate any risks;

• Issues, recommendations, and escalation measures; and

• Progress against task order service level metrics;

d. Collecting system and performance metrics associated with each task area, as will be defined in each Task Order;

e. Proactively informing FDA of any issues, problems and recommendations that should be addressed in order for the overall effective accomplishment of task order goals. Recommendations for actions that need to be taken by FDA or other contractors shall be clearly defined and communicated to FDA and have identified dates for completion.

f. Prepare materials for, and participate in meetings including, but not limited to:

program reviews, management briefings, and other similar meetings. Preparing for and participating in Program Status Review meetings and In-Process Review meetings, in accordance with the terms of this contract (see Section 7.2) and the applicable task order.

g. Participating in a Kick-Off Meeting at a date and time of FDA’s choosing prior to commencement of any inspections. The Kick-Off Meeting may be conducted remotely via teleconference or videoconference

h. Facilitating processing of background investigations and FDA Commissions, providing timely notification of personnel changes to FDA, and ensuring timely execution of any required follow-up actions related to onboarding new Contract personnel (e.g., initiating background investigations) or processing outgoing personnel (e.g., return of credentials and equipment).

i. Securing a signed FDA Form 3398 for each Contractor employee and substantially similar agreement from each subcontractor who is or will be involved in the inspection program under this Contract or who has or will have access to any non-public information arising under or related to this Contract.

j. Securing and maintaining all required information and documents pertaining to inspectors, including maintaining current contact information for currently-employed inspectors and former inspectors who conducted inspections within the past five years.

k. Monitoring and providing timely notification to FDA of any actual, apparent, or potential conflicts of interest for any Contractor or subcontractor personnel, and otherwise ensuring that all statutory and contractual requirements relating to conflicts of interest are met.

l. Facilitating timely implementation and completion of all training requirements for all employees or subcontractor employees under this Contract.

m. Ensuring all statutory and contractual requirements for inspection procedures are communicated, implemented, and followed by all Contractor and subcontractor employees.

n. Ensuring timely completion of all inspection assignments and timely submission of all deliverables.

o. The Contractor is responsible for ensuring the quality, completeness, accuracy, adequacy, and contractual compliance of all services, deliverables, and delivered information under this contract and any Task Order. All services shall conform to all contractual and Task Order requirements, and all deliverables and delivered information shall be complete, accurate, and useable by FDA.

Activity 3-Complete FDA training session for inspectors

All Contractor and subcontractor personnel performing under the Contract must complete an initial training session conducted by FDA prior to performing any work under the Contract. The training will address FDA inspectional jurisdiction, how to conduct inspections, completion of inspectional forms, gathering hardcopy documentary evidence, photographing evidence, submitting forms and evidence to FDA, the importance of protecting non-public information, and the consequences of unauthorized disclosure of non-public information.

Inspectors must have their background investigation completed and cleared prior to reviewing the training materials. Training may be conducted remotely via live videoconference with FDA officials. The Contractor must ensure that all parts of the FDA-mandated training are implemented as prescribed and that all Contractor and subcontractor personnel performing under the Contract complete the required training.

Any Contractor or subcontractor personnel hired after the initial training session has been conducted by FDA must complete a training session prior to commencing work under the Contract or conducting any inspections. Upon hiring personnel to perform under the Contract, the Contractor or subcontractor shall promptly contact the FDA to schedule that second training session, and FDA will select a date and time to conduct remote training Commissioned inspectors who make multiple or repeated procedural errors shall be required to complete a mandatory refresher training session. FDA shall identify and notify commissioned inspectors subject to the mandatory refresher training requirement, and FDA will select a date and time to conduct remote refresher training via live videoconference not to exceed two hours in length.

Once the Contractor or any subcontractor receives notice from FDA regarding an inspector subject to the mandatory refresher training requirement, that inspector shall not conduct any inspections until he/she has completed the refresher training course.

Activity 4- Conduct Inspections

Inspect establishments engaged in the manufacture, assembly, preparation, compounding, processing, packing or repacking, labeling or relabeling, or holding of regulated tobacco products for introduction into interstate commerce or after such introduction to document compliance with all applicable provisions of the Food, Drug and Cosmetic Act, including but not limited to:

Sections 903(a)(1), 903(a)(7)(A), 910, and 911 of the FD&C Act (21 U.S.C. § 387c(a)(1);

21 U.S.C. § 387c(a)(7)(A); 21 U.S.C. § 387j; 21 U.S.C. § 387k).

The Contractor shall inspect all establishments designated on quarterly lists provided by FDA. Inspections of all establishments designated on each quarterly list shall be completed within the quarter to which they are assigned. Lists shall be provided by FDA 30 calendar days prior to the beginning of each quarter and shall encompass establishments located within the United States and territories. For purposes of this clause, “quarter(s)” refers to the quarters comprising the Federal fiscal year (October 1 through December 31; January 1 through March 31; April 1 through June 30; July 1 through September 30).

During each inspection, the Contractor shall complete the following tasks:

1. Complete and present to the establishment an original, properly executed, and signed Form FDA 482 (Notice of Inspection). The Contractor shall retain a copy of the signed Form FDA 482 for submission to FDA.

2. Complete an inspectional form provided by FDA. An inspectional form shall contain at least fifteen questions pertaining to the following categories of information:

a. Administrative information about the establishment, potentially including but not limited to the following information: name, address, city, state, size of establishment, hours of operation.

b. Inspectional questions related to all applicable provisions of the Food, Drug and

Cosmetic Act, including but not limited to: Sections 903(a)(1), 903(a)(7)(A), 910, and 911 of the FD&C Act, potentially including but not limited to the following topics:

• Establishment is a retailer, manufacturer, or both.

• Products the establishment manufactures.

• Establishment imports or exports regulated tobacco products.

• Establishment is potentially in violation of Sections 903(a)(1) or 903(a)(7)(A) of the FD&C Act, which prohibit false or misleading labeling and advertising for regulated tobacco products.

• Establishment is potentially in violation of Section 910 of the FD&C Act, which prohibits introducing or delivering for introduction into interstate commerce any “new tobacco product” without an order from FDA authorizing the marketing of the product.

• Establishment is potentially in violation of Section 911 of the FD&C Act, which prohibits introducing or delivering for introduction into interstate commerce any “modified risk tobacco product” without an FDA order in effect.

The Contractor shall observe, review, request, or otherwise obtain access to all information necessary to complete the inspectional form and provide FDA with all information requested therein.

FDA may generate multiple versions of the inspectional form, but all versions shall conform to the parameters of this section.

3. Take photographs of evidence pertaining to the information requested in the inspectional form. The Contractor may be required to photograph evidence including but not limited to documents, written procedures, brochures, products, signage, advertising, and labeling. All photographs must be clear, any inspector’s writing in the photograph must be legible (if applicable), and the photograph must fully capture the required information.

The Contractor shall use FDA-furnished handheld devices to take photographs of evidence and electronically submit such photographs to FDA. Use of any other equipment to take photographs during an inspection, or to store or transmit such photographs at any time, is prohibited.

Inspections shall not be considered complete until the Contractor has compiled all information requested in the inspectional form, obtained the signed form 482, and obtained clear photographs of all evidence requested by FDA in the inspectional form, except to the extent that any such information, Form 482, or photograph is not obtainable or collectable under the inspectional authorities granted to FDA in 21 U.S.C. §§ 372-74 and 21 U.S.C. § 387e (available at https://www.gpo.gov/fdsys/browse/collectionUScode.action?collectionCode=USCODE) or the establishment denies access to any information or evidence properly and diligently requested by the Contractor.

The Contractor shall conduct inspections in accordance with the applicable provisions of the FD&C Act). Procedural requirements for all inspections include, but are not limited to, the following:

1. The Contractor shall present FDA-issued credentials and an original, properly executed, and signed Form FDA 482 (Notice of Inspection) to the owner, operator, or agent in charge of the establishment. The Contractor shall retain a copy of the signed Form FDA 482 for submission to FDA.

https://www.gpo.gov/fdsys/browse/collectionUScode.action?collectionCode=USCODE

The Contractor may take actions authorized under 21 U.S.C. §§ 373-74 that are necessary to obtain the information and evidence required by FDA under this Contract, including but not limited to the following statutorily-authorized actions:

1. Entry of any establishment in which regulated tobacco products are manufactured, processed, packed, or held.

2. Inspection of:

a. All pertinent equipment, finished and unfinished materials, containers, and labeling therein.

b. All things therein (including records, files, papers, processes, controls, and facilities) bearing on any violation of the FD&C Act, including whether regulated tobacco products which are adulterated or misbranded within the meaning of the FD&C Act, or which may not be manufactured, introduced into interstate commerce, or sold, or offered for sale by reason of any provision of the FD&C Act, have been or are being manufactured, processed, packed, transported, or held in any such place.

In accordance with 21 U.S.C. § 374, inspections shall not encompass inspection or review of any financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to the FD&C Act), and research data (other than data relating to tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to Chapter IX of the FD&C Act (21 U.S.C. § 387 et seq.)).

If an inspection cannot be completed, the Contractor must notify FDA within five (5) business days of initiating the inspection. Notification of an incomplete inspection must be submitted electronically via email to the FDA and must include an explanation of the reason(s) why the inspection could not be completed.

c. Evidence Storage

The Contractor shall ensure proper collection, handling, sealing, documentation, storage, and submission of evidence pursuant to FDA protocol to ensure that evidence is maintained in a manner that shall allow FDA to use the evidence to support an enforcement action. The Contractor shall store evidence for the duration of the contract and shall perform a single transfer of all evidence to FDA or an FDA contractor prior to the end of the contract. The contractor must be capable of being promptly furnished to FDA upon request.

Activity 5 - Provide support services related to FDA enforcement actions

The Contractor shall take reasonable actions to ensure that inspectors employed by the Contractor shall be available to testify as witnesses, if and when requested by FDA, in administrative hearings and court proceedings related to inspections they conducted. The Contractor shall maintain current contact information for all inspectors currently employed by the Contractor and shall provide FDA with current contact information for any currently-employed inspector within five (5) business days of request. The Contractor shall attempt to maintain and annually verify current contact information for all inspectors who were employed within the past five years but are no longer employed by the Contractor, and the most recent contact information for formerly-employed inspectors shall be provided to FDA within five (5) business days of request.

Submit completed inspectional form, signed Form FDA 482, and all photographs of evidence to FDA within five (5) business days of initiating the inspection.

The Contractor shall submit the completed inspectional form and the signed Form FDA 482 to the FDA within five (5) business days of initiating the inspection. If hard copies of the Form FDA 482 are required, they must be transmitted to FDA by a commercial shipping service that tracks shipments and provides delivery confirmation. The completed inspectional form shall be submitted electronically via the FDA-furnished handheld device.

The Contractor shall electronically submit all photographs of evidence to the FDA within five (5) business days of initiating the inspection. All photographs collected during an inspection must be submitted to the FDA directly from the Contractor’s FDA-furnished handheld device.

The Contractor shall respond to any FDA request for clarification regarding incomplete, inaccurate, unclear, or deficient submissions of inspectional forms, FDA 482 forms, collected hardcopy documentary evidence, if available, or photographs of evidence within two (2) business days of receiving such request. Responses shall be submitted to the FDA official that submitted the request for clarification. The contractor will not be required to return to a facility to acquire additional information in conjunction with that specific inspection assignment. If and when necessary, follow up actions will consist of inspectors or key personnel responding to emailed inquiries requesting clarification regarding submitted inspection results, forms, or photos. Responses via email or phone call shall be required.

Activity 6 -Transition-out

The Contractor shall provide transition-out services, if applicable, to facilitate the transition of contracted activities and services to the Federal Government or to a follow-on Contractor at the end of the period of performance of the Task Order or contract.

The Contractor shall provide transition out activities, including creating and implementing a transition out plan and leading Technical Exchange Meetings (TEMs) with the successor to impart knowledge of all processes, systems, applications, and databases. During this period, the Contractor shall ensure no degradation in support provided under the task order. Between the COR-designated turnover date and the end of the applicable task order period of performance, the outgoing Contractor shall ensure all task order activities are closed out and provide sustainment support to complete the transition.

Representative transition-out duties under each Task Order include:

1. Providing the succeeding contractor or FDA (if no succeeding contractor), whichever is applicable, with all current contact information for all inspectors and minors currently employed by the Contractor and any subcontractor(s) and all current contact information for all inspectors and minors who participated in an FDA inspection within the past five years while employed by the Contractor, any subcontractor, or a preceding contractor.

2. Providing FDA with a current inventory of all Government-owned assets possessed or used by the Contractor along with full support in the reconciliation of this inventory. The inventory shall include all physical evidence and FDA-furnished equipment, and the Contractor shall provide the completed inventory log to FDA with the date that the packages are being shipped to FDA.

3. The Contractor shall gather and return the following items using FDA-provided shipping label(s):

a. FDA issued handheld devices with each device’s accessories (including cases, chargers, and/or styluses) from each inspector with a list of the inventory.

b. Unused FDA materials, including Form FDA 482.

c. All government-furnished equipment and any other equipment for which title vests in the government under any clause of the contract or task order.

Additional details, including the length of the transition-out period, shall be specified at the task order level.

C. 4 KEY PERSONNEL

The Contractor shall designate a Program Manager who shall be responsible for overall Contract coordination and communicating with FDA. The Program Manager shall be responsible for all aspects of the program management work described herein. This position shall be the main point of contact for FDA.

352.237-75 Key Personnel. (December 18, 2015)

The key personnel specified in this contract are considered to be essential to work performance.

At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of clause)

C. 5 LABOR CATEGORY DESCRIPTIONS

Program Manager Organizes, directs, and coordinates the planning and execution of all activities and personnel associated with inspection services project. Responsible for customer satisfaction and delivering high levels of quality and timely information as required by the SOW. Meets or exceeds customer expectations by developing and delivering insightful, value-added solutions that address potential customer issues. Demonstrates strong written and oral communication skills and functions as the main point of contact with FDA. Remains current on industry and market trends to anticipate and identify new business challenges and customer issues to ensure the success of the project, Program Coordinator Under supervision of the Program Manager, shall assist with the planning and execution of all activities and coordination with personnel associated with inspection services. Program Coordinator responsibilities include working closely the Program and liaising with Inspectors to ensure that inspection goals are met. Administrative duties, such as maintaining project documentation and inspection reports are important. Excellent time management and communication skills are required as you’ll collaborate with internal team members and FDA to ensure contract deliverables are met.

Inspector (Commissionable) Must be a state employee and be able to obtain credentials and commission to conduct inspections in compliance with provisions of the Food, Drug and Cosmetic Act. Must be able to coordinate inspections as well as accurately record information collected from inspection sites for reporting purposes. Must have strong communication skills to communicate with retail sites being inspected as well as the Program Manager and Program Coordinator to convey appropriate information. Additionally, inspectors may be required to testify as witnesses in administrative hearings during the period of performance of the contract.

A FDA commission is a delegated authority from the Commissioner of Food and Drugs to an individual to act on his/her behalf. A health, food, or drug officer or employee of any State, Territory, or political subdivision thereof (herein referred to as "state and local officials") may be commissioned to conduct examinations and investigations on FDA’s behalf for the purposes of the Act.

Inspectors that do not perform a minimum of 10 inspections per month will be deactivated from the program.

SECTION D - PACKAGING AND MARKING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with the Government specifications below. At a minimum, all deliverables shall be marked with the contract number and contractor name.

https://resources.workable.com/project-manager-job-description

1. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

2. The Contractor shall scan all deliverables for viruses before submitting to the FDA.

3. Deliverables under this contract shall be prepared and packaged for shipment using standard shipping practices to ensure safe and timely delivery.

SECTION E - INSPECTION AND ACCEPTANCE

The FDA COR will inspect and make acceptance decisions for all materials, documents, and services provided under this contract. For the purpose of this Section, the FDA COR is the authorized representative of the Contracting Officer.

52.246-4 - Inspection of Services - Fixed-Price (AUG 1996) 52.246-6 - Inspection - Time-and-Material and Labor-Hour (MAY 2001)

SECTION F - DELIVERIES OR PERFORMANCE

F.1 ANTICIPATED DELIVERABLES

Note: Actual deliverables, deliverable schedules, Progress Reports and Status meetings shall be established in the issuance of each individual task order. Additional Reporting Requirements may be included in each Task Order.

Progress Reports - The Contractor shall submit one (1) electronic copy of the Progress Report to the COR and Contracts Specialist. The report shall include a status update on each task worked on and deliverables submitted, any problems encountered, and suggestions for addressing problems each period. If the tasks are cost reimbursable in nature, an accounting of applicable staff who worked on the tasks as well as any deviations from the original projection of hours planned vs. actually incurred will be required.

The Contractor shall submit monthly metrics reports to FDA by the 10th business day of the following month. Monthly reports must accurately track the following metrics:

• Number of establishments assigned for the quarter;

• Number of inspections completed;

• Number of establishments pending inspection;

• Number of inspections not completed identified by reason (e.g., refusal, or investigator unable to meet quota for the quarter).

Monthly reports shall be submitted electronically as a “PDF” attachment emailed to the Contracting Officer’s Representative (COR).

Program Status Review meetings (PSRs)- The Contractor shall facilitate and participate in PSR meetings as needed. PSRs shall be held in person at the Contractor’s facility or remotely http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/52_246.htm#P114_24164 via teleconference, at FDA’s discretion. PSRs shall encompass review of Contractor’s overall performance under the applicable task order, quality and quantity of services (including review of inspection services, results, and all facets of performance), quality and timeliness of deliverables, and any other issues pertaining to performance of the task order under this contract.

If requested by FDA, the Contractor shall provide advance copies of all relevant performance and QA data requested by FDA prior to a scheduled PSR.

F.2 ORDERING PERIOD

Task Orders may be issued up to the final day of this contract, and the contract shall remain in force to allow for the completion of all task orders issued. However, the Government shall not issue, and the Contractor shall not accept any new task orders issued subsequent to the performance period of this contract.

F.3 PERIOD OF PERFORMANCE

The period of performance for the base period of the contract shall be one (1) year from the effective date of the contract.

Base Year Dates TBD

F.4 OPTION PERIODS

Option PERIOD

Option Period One (1) One (1) year from the effective date of the base period award

Option Period Two (2) Two (2) years from the effective date of base period award

Option Period Three (3) Three (3) years from the effective date of the base period award

Option Period Four (4) Four (4) years from the effective date of base period award

F.5 PLACE OF PERFORMANCE

The place of performance will be specified at the Task Order level. Task orders may be issued for performance in any of the United States or its territories.

SECTION G - CONTRACT ADMINISTRATION DATA

G.1 ORDERING PROCEDURES

Ordering services under this contract shall be accomplished by the issuance of written task orders specifying the inspection services required by State. All task orders issued under this contract shall conform to the provisions of the contract clauses in Section 7 entitled “Ordering.” The only office authorized to process task orders through the Office of Acquisitions & Grants Services is the Food and Drug Administration (FDA) Contracting Officer.

TASK ORDER PROCESSING

All task orders issued hereunder are subject to the terms and conditions of this contract.

This contract shall control in the event of conflict with any task order. A task orders shall be “issued” for purposes of this contract upon the effective date of the order.

The general process for individual task orders is as follows:

a) The FDA will prepare a statement of work. The SOW will include, at a minimum, the following elements:

1. Description of work in terms of the purpose or objectives of the work and location to be performed.

2. Description of how the work performance is assessed relative to objectives, goals, and outcomes.

3. Period and place of performance

4. Reporting requirements and deliverables

5. Whether the order will be fixed price, labor hour, time and material or a hybrid type task order.

b) Requests for Task Order Proposals (RTOPs) shall only be issued by the Contracting Officer.

c) The Contractor shall prepare and submit a task proposal addressing all areas of the requirement. The Contractor shall submit the task proposal within the time period specified in the RTOP and adhere to the ceiling rates established in the contract. No separate payment will be made to the contractor for the cost to prepare, submit and/or negotiate a task order proposal.

The Government shall evaluate task order proposals for technical acceptability and price reasonableness.

G.2 CONTRACTING OFFICERS REPRESENTATIVE (COR)

The following COR will represent the Government for the purpose of this contract: (To Be Determined Upon Contract Award)

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

G.3 CONTRACTING OFFICER (CO)

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in a task order; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract;

or (5) otherwise change any terms and conditions of this contract.

The contact information for the Contracting Officer is:

Matthew J. Bucher 5630 Fishers Lane Rockville, MD 20857 Email: Matthew.Bucher@fda.hhs.gov Tel: (240) 402-7566

The contact information for the Contract Specialist is:

Christopher R. McGucken 5630 Fishers Lane Rockville, MD 20857 Email: Christopher.McGucken@fda.hhs.gov Tel: (240) 402-7566

G.4 INVOICE SUBMISSION

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Office of Financial Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov *** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite- Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment);

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;

(xi) Name and telephone number of the FDA Approving Official (i.e., Contracting Officer (CO) or Contract Specialist (CS), as referenced in the award document);

(xii) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced in the award document;

(xiii) Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiv) Any other information or documentation required by the contract/order award.

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the FDA Payment Office at the e-mail address or phone number provided above in Section A.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 CONTRACTOR PERFORMANCE EVALUATION(S)

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation.

The Contractor has 30 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3 year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov.

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.gov/allapps/cpcbtdlf.htm. There is no fee for registration or use of the CPARS.

H.2 SECURITY REQUIREMENTS

All proposed contractor personnel are subject to the security requirements delineated in the FDA Security Article entitled, Contractor Personnel Security Clearance Standards and Residency Requirements, dated October 2017, as found in this solicitation. This includes the requirement pursuant to Homeland Security Presidential Directive-12 (HSPD-12), that proposed personnel must have resided in the U.S. for a total of at least three (3) of the past five (5) years. All Offerors must inquire with all proposed personnel to ensure each individual meets such residency requirements prior to submittal of any key personnel, management or staffing plans in response to this solicitation. Thus, any proposal submitted in response to this solicitation will constitute an implied certification that all such residency requirements have been met.

Offerors are hereby notified that noncompliance with the subject FDA Security Article may detrimentally impact eligibility for award, and remain grounds for cancellation, equitable adjustment, or termination after award.

PART II

SECTION I - CONTRACT CLAUSES

I.1 HHSAR CLAUSES INCORPORTATED BY REFERENCE

This contract incorporates one or more clauses by reference with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at:

http://www.hhs.gov/policies/hhsar/subpart301-1.html.

352.203-70, Anti-Lobbying (DEC 2015) 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (DEC 2015) 352.223-70, Safety and Health (DEC 2015) 352.227-70, Publications and Publicity (DEC 2015) 352.239-74, Electronic and Information Technology Accessibility (DEC 2015) 352.239-73, Electronic Information and Technology Accessibility Notice (DEC 2015)

I.2 52.252-2 FAR CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at:

www.acquisition.gov/far/index.html.

52.216-7, ALLOWABLE COST AND PAYMENT (JUN 2013)

52.227-17, RIGHTS IN DATA – SPECIAL WORKS (DEC 2007)

52.232-40, PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS

SUBCONTRACTORS (DEC 2013)

I.3 FAR CLAUSES BY FULL TEXT

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders Commercial Items (NOV 2017).

As prescribed in 12.301(b)(4), insert the following clause:

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further http://www.hhs.gov/policies/hhsar/subpart301-1.html http://www.acquisition.gov/far/index.html https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2012_3.html#wp1084399 https://www.acquisition.gov/sites/default/files/current/far/html/52_200_206.html#wp1158787

Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(3) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(4) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004)(Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

X (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C.

3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

X (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

X (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred,…