RFP-75F40123R00049.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

CODE 16. ADMINISTERED BYCODE

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X

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORDAP

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

07/19/2023 1400 ET

06/29/2023

215-717-3093JANICE HEARD

(No collect calls)

INFORMATION CALL:

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

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75F40123R00049

5. SOLICITATION NUMBER

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

1 92 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

Beltsville MD 20705 4041 Powder Mill Road ATTN: Janice Heard

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

11.

SEE SCHEDULEX

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/DAP

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

X

24.

AMOUNT

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UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Vape Inspection - Indefinite Delivery Indefinite Quantity (IDIQ) Contract

The contractor will provide Vape Inspections to inspect establishments engaged in the manufacture, assembly, preparation, compounding, processing, packing, or repacking, labeling, or relabeling, or holding of regulated tobacco products (manufacturers) to document compliance with certain provisions of the FD&C Act.

Period of Performance: 09/10/2023 to 09/09/2028

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

HEREIN, IS ACCEPTED AS TO ITEMS:

DATED

ERIKA A. EAM

. 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

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

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

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

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:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

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

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

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

19.

ITEM NO.

1 Vape Retail Inspections - Year 1

09/10/2023 - 09/09/2024

Period of Performance: 09/10/2023 to 09/09/2024

2 Vape Retail Inspections - Year 2

09/10/2024 - 09/09/2025

Period of Performance: 09/10/2024 to 09/09/2025

3 Vape Retail Inspections - Year 3

09/10/2025 - 09/09/2026

Period of Performance: 09/10/2025 to 09/09/2026

4 Vape Retail Inspections - Year 4

09/10/2026 - 09/09/2027

Period of Performance: 09/10/2026 to 09/09/2027

5 Vape Retail Inspections - Year 5

09/10/2027 - 09/09/2028

Period of Performance: 09/10/2027 to 09/09/2028

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

92 2 of

75F40123R00049

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

Continuation of Standard Form (SF) 1449 The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-04 effective June 2, 2023. All Task Orders (TOs) issued are subject to the terms and conditions of this Indefinite Delivery, Indefinite Quantity (IDIQ) contract. This contract shall control in the event of conflict with any Task Order (TO).

B.1 GENERAL

(a) The contractor will provide services associated with inspection of retail establishments in compliance with certain provisions of the FD&C Act.

(b) The contract term is a total of five (5) years, with five (5) one year ordering periods; and

(c) The contract will be for Commercial Services, IDIQ contract firm fixed unit prices (labor rates), and cost reimbursement line items for other direct costs and travel.

(d) The TO periods of performance may be any duration during the period of performance of the IDIQ but shall not exceed one (1) year after the end of the period of the IDIQ.

B.2 MINIMUM AND MAXIMUM AMOUNTS

(a) The guaranteed minimum amount for this contract is $10,000.00 and will be obligated at time of award.

(b) There are no maximum quantities or amounts for each individual line item, TO, contract period, or contract. The estimated value is $8,000,000.00 for the entire period of performance of the contract.

(c) At the discretion of the Contracting Officer (CO), the Government may use a variety of contract types when issuing TOs under this contract, including Firm-Fixed-Price (FFP), Time and Materials (T&M), Labor Hour (LH), or a combination thereof. Each Request for TO Proposal (RFTOP) issued under this contract will identify the Government’s determination of contract type.

(d) Funding will be provided at the time that an order is issued.

B.3 PRICE SCHEDULE

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”.

All unit prices are fixed unit prices that include all costs (including, but not limited to: labor, fringe benefits, overhead, G&A, and profit, if applicable) necessary to provide the services required in the solicitation/contract.

The labor categories indicated below may be ordered throughout the duration of the contract as needed.

• Estimated Level of Effort – hours annually are provided for evaluation purposes only.

The estimated hours shown in the tables below are provided for the purpose of evaluation and are not an assurance of work to be ordered. At the time the IDIQ is issued the estimated hours and extended price will be deleted leaving only the Labor Category, and Labor Hourly Rate. Price discounts are requested for the establishment of the IDIQ and for all orders exceeding the simplified acquisition threshold. Price reductions may also be requested prior to placing an order under the simplified acquisition threshold or in conjunction with the annual IDIQ review.

* Hourly Rates – The fixed hourly rate listed are "Fully Burdened".

Labor Category Estimate Level of Effort – Hours

Annually

Period 1 Hourly Rates* (Base)

Period 2 Hourly Rates*

Period 3 Hourly Rates*

Period 4 Hourly Rates*

Period 5 Hourly Rates*

TOTAL

Program Manager 1040

Program Coordinator

Inspector 28750

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

Expense Not-To- Exceed

(NTE)

Period 1

Not-To- Exceed

(NTE)

Period 2

Not-To- Exceed

(NTE)

Period 3

Not-To- Exceed

(NTE)

Period 4

Not-To- Exceed

(NTE)

Period 5 Other Direct Costs $5,000.00 $5,125.00 $5,255.00 $5,385.00 $11,060.00

Travel Not-To-Exceed

(NTE)

Period 1

Not-To-Exceed

(NTE)

Period 2

Not-To-Exceed

(NTE)

Period 3

Not-To-Exceed

(NTE)

Period 4

Not-To-Exceed

(NTE)

Period 5 Travel $400,000.00 $412,000.00 $412,000.00 $412,000.00 $412,000.00 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. The Program Manager should equal at least one (1) Full-time Equivalent (FTE) per task. For the purposes of this contract an FTE equals 2080 hours.

Program Coordinators

Under supervision of the Program Manager, Program Coordinators shall assist with the planning and execution of all activities and coordination with personnel associated with inspection services. Program Coordinators responsibilities include working closely the COR and liaising with Inspectors to ensure that inspection goals are met. Administrative duties, such as maintaining project documentation and inspection reports are required. Excellent time management and communication skills are required for collaborating with internal team members and FDA to ensure contract deliverables are met. The Program Coordinators should equal at least one (1) Part-Time Equivalent (PTE) per task. For the purposes of this contract an PTE equals 1040 hours.

Inspector

An FDA commission is a delegated authority from the Commissioner of Food and Drugs to an individual to act on his/her behalf. United States citizens may be commissioned to conduct examinations and investigations on FDA’s behalf for the purposes of the Act under the authority of Section 702(a)(1)(A) of the FD&C Act (21 U.S.C. § 372(a)(1)(A)), which includes any health, food, or drug officer or employee of any State, Territory, or political subdivision thereof (herein referred to as “state and local officials”).

Inspectors must be able to execute inspections as well as accurately record information collected from inspection sites for reporting purposes. Inspectors must have strong communication skills to communicate with the establishment personnel and to appropriately convey information to the Program Manager and Program Coordinator. Additionally, Inspectors must be available to testify as witnesses in administrative hearings during the period of the task order.

B.4 STATEMENT OF WORK

A. 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.

B. OBJECTIVE

The purpose of this IDIQ is to inspect establishments engaged in the manufacture, assembly, preparation, compounding, processing, packing, or repacking, labeling, or relabeling, or holding of regulated tobacco products (“manufacturers”) to document compliance with certain provisions of the FD&C Act. FDA will utilize the information and evidence collected during inspections to document manufacturers’ compliance with applicable requirements and to 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 administrative and enforcement actions authorized by the FD&C Act, including, but not limited to, warning letters, civil money penalties, no-tobacco-sale orders, and injunctions.

C. 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 FD&C Act, including but not limited to: Sections 903(a)(1), 903(a)(7)(A), 910, and 911 (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 “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.

The Contractor shall be capable of employing individuals who are eligible to be commissioned in accordance with Section 702(a)(1)(A) of the FD&C Act (21 U.S.C. § 372(a)(1)(A)) which reads in part “The Secretary is authorized to conduct examinations and investigations...through any health, food, or drug officer or employee of any State, Territory, or political subdivision thereof, duly commissioned by the Secretary.”

C.1 Conducting inspections and providing related support services

There are no deliverables under the overarching IDIQ. The Contractor shall abide by program changes needed to maintain the efficiency of program operations and accuracy of data and evidence collection. The Government will issue tasks under this IDIQ to provide the following activities:

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.

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

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

b. Conducting and coordinating all onboarding activities and obtaining and submitting all required paperwork, badging, and commissions for all applicable Contractor personnel.

c. Participating in Transition‐In meetings and knowledge transfer activities.

d. Ensuring 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 currently employed by the incumbent contractor and any subcontractor(s) and all current contact information for all Inspectors and Underage Buyers 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. The Program Management 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;

Maintenance of Quality Assurance (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; and Mitigation of risks and other performance issues as they arise.

b. Ensuring inspection results are submitted into FDA systems electronically by Inspectors by the end of the day of 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. Providing monthly progress reports to FDA by the 10th business day of the following month. T h e monthly progress reports must accurately track metrics described in greater detail in section F.1. Additional contents and format of monthly progress reports will be specified at the Task Order level, and may encompass some or all 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 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. Preparing materials for, and participating in meetings including 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 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. 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(s) for Inspectors

Initial Training

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 and have signed a Form FDA 3398 prior to reviewing the training materials. Training may be conducted remotely via live videoconference with FDA officials. Training shall consist of 1-2 hours for New Hires. Contractor must complete Ad-hoc training throughout the year, which consist of an additional 8 hours yearly (see Ad-hoc training below for more information). 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 the training session, and FDA will select a date and time to conduct remote training.

Ad-hoc Training

In addition to the initial training, FDA may provide additional ad-hoc inspectional guidance and reference materials based on evolving vape establishment operations and CTP priorities. Ad-hoc training shall consist of an additional 8 hours yearly. Commissioned Inspectors must confirm receipt and review of any ad-hoc materials with Program Coordinators and FDA. Examples of guidance and reference materials include Inspection Best Practices, Inspection Talking Points, updated inspection strategies and techniques, etc.

Refresher Training

Using the feedback function through the web application the contract will be able review feedback with the Inspectors that is provided by the FDA. FDA shall notify the Program Manager (PM) and/or Program Coordinators (PC) about concern(s) or reason(s) for additional training (i.e., refresher training) due to deficiency with an inspector's work. 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, twice a year.

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

Activity 4- Conduct Inspections

The Contractor shall inspect establishments engaged in the manufacture, assembly, preparation, compounding, processing, packaging or repackaging, 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 (FD&C Act), including:

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 lists provided by FDA or as directed based on the programmatic assignment. FDA will designate the establishments to be inspected via establishment lists to be provided to the Contractor on a recurring basis no more frequently than monthly and no less frequently than quarterly. The lists shall encompass establishments located within the United States and Puerto Rico. The number of establishments the contractor will inspect annually shall not exceed 2,000.

Once FDA provides the establishment list to the Contractor, the Contractor must begin conducting the inspections within fifteen (15) calendar days of receipt of the list. The Contractor shall complete the inspections within forty-five (45) calendar days of receipt of the list.

FDA may direct the Contractor to prioritize the establishment to be inspected based on the Agency’s enforcement priorities. The number of firms prioritized for inspections shall not exceed 100 annually. FDA shall, at its sole discretion, provide additional inspection lists to the Contractor. FDA can request the Contractor to prioritize the inspections of the manufacturers included in these lists. The Contractor shall have thirty (30) calendar days from the FDA’s issuance of the prioritized lists to conduct every inspection included in said list.

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. 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. An inspectional form shall contain at least fifteen (15) questions pertaining to the following categories of information:

a. Administrative information about the establishment, potentially including the following information: name, address, city, state, size of establishment, and hours of operation.

b. Inspectional questions related to all applicable provisions of the Food, Drug and Cosmetic Act, including: Sections 903(a)(1), 903(a)(7)(A), 910, and 911 that provide information on the following topics:

Whether the establishment is a retailer, manufacturer, or both.

Products the establishment manufactures if the establishment is a manufacturer.

Whether the establishment imports or exports regulated tobacco products.

Whether the 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.

Whether the 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.

Whether the 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.

3. Take photographs of evidence pertaining to the information requested in the inspectional form. The Contractor may be required to photograph evidence including 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.

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

4. 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 FDA 482, and obtained clear photographs of all evidence requested by FDA in the inspectional form, except to the extent that any such information, Form FDA 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 shall ensure that 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.

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 the following statutorily authorized actions:

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

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 two (2) 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.

Costs incurred due to Contractor’s failure to follow FDA inspection process will be the sole responsibility of the contractor.

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 transfer of identified evidence as requested to FDA or an FDA contractor prior to the end of the contract. The Contractor must be capable of promptly furnishing the evidence to FDA upon request.

d. Sample Collection:

FDA may request the Contractor to collect product samples and submit to FDA. When the Contractor is conducting sampling, the Inspector must only request samples that are approved Tobacco products. FDA will provide the Contractor the information required to perform the process.

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, 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 within two (2) business days of request. The Contractor shall maintain and annually verify current contact information for all Inspectors who were employed within the past five (5) 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 two (2) business days of request.

The Contractor shall submit the completed inspectional form and an electronic copy of the signed Form FDA 482 to the FDA by the end of the day of the inspection. The completed inspectional form shall be submitted electronically via the FDA-furnished handheld device.

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 Contractor shall electronically submit all photographs of evidence to the FDA by the end of the day of 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 Form 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 COR 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 in order to respond to requests for clarification. 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. The Contractor shall respond via email or phone call.

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(s). The outgoing Contractor shall ensure all Task Order(s) activities are closed out and provide sustainment support to complete the transition between the Contracting Officer’s Representative (COR) designated turnover date and the end of the applicable Task Order(s) period(s) of performance.

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 the Contractor and any subcontractor(s) and all current contact information for all Inspectors and Underage Purchasers who participated in an FDA inspection within the past five (5) 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 with 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.

GOVERNMENT FURNISHED PROPERTY (GFP)

It is possible that the Government may provide and deliver electronic handheld devices to the Contractor. It is also possible that the FDA will replace these specific units when updates are made to the software application.

The Government will provide 2 laptops to the contractor. All property associated with the performance of the services will be distributed at the Task Order Level.

Equipment Return - Upon the departure or reassignment of an Inspector, or upon expiration of the Contract ALL IT equipment provided by FDA for the Inspector or Contractor, respectively, shall be returned to the COR within ten (10) business days of the inspector’s departure.

Immediately upon discovery (i.e., at least within (one) 1 business day of discovery) that an FDA mobile device, laptop or FDA credential has been lost or stolen, the PC must notify FDA and complete a police report to document the loss or theft. FDA mobile devices must never be taken out of your jurisdiction or used for non-contract purposes.

CONTROL OF PROPERTY

In addition to the applicable "Government Property" clause in Section I, the Contractor shall comply with the provisions of DHHS publication "Contractor's Guide for Control of Government Property," which is hereby incorporated by reference. The guide is available on the HHS website:

https://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf.

https://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf

All references in the Guide to the acquisition cost threshold for accountable property are changed to $5,000.

The Contractor shall inventory all accountable Government property and submit a list of that property to the Contracting Officer on commencement of the Contract, usually concurrent with transfer of the property, annually on the anniversary of contract award, and within 90 calendar days after completion or termination of the Contract.

The inventory list, reflecting each item of accountable property as a separate line item, should contain the following data elements:

1. Barcode/tag number

2. Item name/description

3. Manufacturer's name

4. Manufacturer's model number

5. Manufacturer's serial number

6. Unit cost

7. Date received/inventoried

8. Contract number

9. Remarks (optional)

REPORT ON ACCESS TO GOVERNMENT PROPERTY

The Contractor shall ensure that all Contractor employees are informed that they are not to use any Government property for personal use. To ensure that the employees are informed of this policy, the Contractor shall submit to the Contracting Officer a monthly report on Access to Government Property. This report shall document and summarize the Contractor’s program for the protection, preservation and maintenance of all Government property, procedures to educate their employees concerning individual responsibilities for Government property, and efforts to monitor and assess the Contractor’s property control system.

KEY PERSONNEL

The Program Manager is considered 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.

The Contractor shall inform the COR when there are any changes to the information for Program Manager, Program Coordinators, Inspectors, (e.g., phone number, e-mail address, status, change of personnel, etc.).

Additional requirements for Key Personnel will be specified in the individual Task Orders pursuant to Health and Human Services Acquisition Regulation (HHSAR) Clause 352.237-75, Key Personnel.

PERIOD OF PERFORMANCE

The period of performance for the contract will be five (5), one (1) year ordering periods. So being, it is anticipated that the total period of performance for this IDIQ will be 60 months (5 years) from the date of award.

Each Task Order will have its own individual period of performance.

PLACE OF PERFORMANCE

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

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.

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.

SECURITY

During the course of performance FDA will provide the Contractor with data that is strictly confidential and shall not be disclosed to other than authorized individuals and organizations. Contractor personnel must sign the provided FDA Form 3398 - Commitment to Protect Non-Public Information within five days of receiving the form and prior to commencing any work involving information under issued tasks. The Form will specify all information designated as non-public.

Where task orders require Contractor access to FDA systems using FDA provided laptops or access to FDA Document Control Centers and Mailrooms, all Contractor personnel utilizing those systems shall complete and sign the equip85, eArrive, and HHS 745 forms in order to be badged and gain systems access. The Contractor shall ensure the completion of these forms. Badging may take 21- 31 business days and the Contractor shall reflect that in the timeline for a task order.

The Contractor shall ensure compliance with IT security requirements, including the following:

DHHS Information Security and Privacy Program http://www.hhs.gov/ocio/securityprivacy/index.html

Federal Information Security Management Act (FISMA) http://www.whitehouse.gov/sites/default/files/omb/memoranda/m 3-19.pdf http://www.whitehouse.gov/sites/default/files/omb/memoranda/m03-19.pdf

National Institute of Standards and Technology (NIST) SP800-53 http://csrc.nist.gov/publications/nistpubs/800-53-Rev3/sp800-53-rev3-final_updated-errata_05- 01-2010.pdf

FDA Security Authorization process, which closely resembles NIST SP800-37 http://csrc.nist.gov/publications/nistpubs/800-37-rev1/sp800-37-rev1-final.pdf

Format and Media: The Contractor shall furnish deliverables in a manner consistent with the FISMA and NIST security requirements of the information provided. For example, the Contractor shall not send Sensitive Personal Identifying Information via e-mail across the internet.

[End of Section B]

SECTION C – CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTSAND

COMMERCIAL SERVICES. (DEC 2022). This clause is incorporated by reference (refer to SF1449 block 27a)

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (Dec 2022), Alternate I (Nov 2021) will apply to any task orders issued on a time and material or labor-hour basis.

ADDENDUM TO FAR 52.212-4:

C.2 ADDITIONAL CLAUSES INCORPORATED BY REFERENCE

This contract incorporates one or more FAR and HHSAR 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 this address:

https://www.acquisition.gov/browse/index/far and http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html http://csrc.nist.gov/publications/nistpubs/800-53-Rev3/sp800-53-rev3-final_updated-errata_05-%2001-2010.pdf http://csrc.nist.gov/publications/nistpubs/800-37-rev1/sp800-37-rev1-final.pdf https://www.acquisition.gov/browse/index/far http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

C.3 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Products and Commercial Services. (JUN 2023)

(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 products and commercial services:

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

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) ( 31

U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (AUG 1996) ( 31 U.S.C. 3553).

Reg Clause Date Clause Title FAR 52.203-16 Jun 2020 Preventing Personal Conflicts of Interest FAR 52.203-17 Jun 2020 Contractor Employee Whistleblower Rights and Requirement

To Inform Employees of Whistleblower Rights

FAR 52.204-4 May 2011 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper

FAR 52.204-12 Oct 2016 Unique Entity Identifier Maintenance

FAR 52.204-13 Oct 2018 System for Award Management and Maintenance FAR 52.204-18 Aug 2020 Commercial and Government Entity Code Maintenance FAR 52.204-19 Dec 2014 Incorporation by Reference of Representations and FAR 52.207-3 May 2006 Right of First Refusal of Employment FAR 52.232-18 Apr 1984 Availability of Funds FAR 52.237-3 Jan 1991 Continuity of Services FAR 52.232-7 Nov 2021 Payments under Time-and-Materials and Labor-Hour Contracts

FAR 52.232-40 Nov 2021 Providing Accelerated Payments to Small Business Subcontractors

FAR 52.242-15 Aug 1989 Stop-Work Order FAR 52.245-1 Sept 2021 Government Property FAR 52.245-9 Apr 2012 Use and Charges https://www.acquisition.gov/far/52.203-19#FAR_52_203_19 https://www.acquisition.gov/far/52.204-23#FAR_52_204_23 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.acquisition.gov/far/52.209-10#FAR_52_209_10 https://www.acquisition.gov/far/52.232-40#FAR_52_232_40 https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/10/3801 https://www.acquisition.gov/far/52.233-3#FAR_52_233_3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

(7) 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 products and commercial services:

[Contracting Officer check as appropriate.] _X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN

2020), with Alternate I (NOV 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 4655).

_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (NOV 2021) ( 41 U.S.C. 3509)).

_X_ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 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…