JA Executed SAM PDF.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES

Office of Acquisitions Routing Slip

Title: Justification and approval for FDA State Tobacco Retail Compliance Check Inspections. Hot item!

For/To: From: Date: Initials: Action being Requested:

Document Preparer Petrina Nelson 05-01-2024 PN Clearance

Supervisor Darrien Demps May 1, 2024 dgd dgd

Clearance

APLOW Jennifer Johnson May 1, 2024

JDJ

Signature

HHS OSDBU Shannon Jackson May 2, 2024 AlD AlD

Signature

Associate Deputy Assistant Secretary for Acquisition

(ADAS)

Anthony Kram May 2, 2024 ASK

ASK

Clearance

SPE/Deputy Assistant Secretary for Acquisition (DAAS)

H. Katrina Brisbon May 2, 2024 kb Signature kb

AOD Control Number:

FDA-24-84

Summary of Requirement: Justification and approval to award a contract to state and territory agencies in accordance with statute. This requirement will support the FDA Program entitled State Tobacco Retail Compliance Check Inspections. The Contractor shall assist FDA in implementing the provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act, and other applicable statutory and regulatory provisions applicable to retailers.

This requirement is a statutory requirement to have compliance inspection conducted utilizing state or territory agencies and is low risk.

Period of Performance:

FY24 – FY29

Dollar Value: $130,820,841.26

Type of Contract: Cost

Requested Actions

X SPE Approval ADAS Approval ASFR Approval

Secretary Approval Deputy Secretary Approval Coordination

X OSDBU Approval X Competition Advocate Approval Discussion

FROM: Petrina Nelson Contact Email: Petrina.Nelson@hhs.gov

Contact Phone:202-841-2283 mailto:Petrina.Nelson@hhs.gov

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Completion Instructions: The Department of Health and Human Services (HHS) has established a standard template for the preparation of a J&A for Other Than Full and Open Competition. If this is an 8(a) set-aside, please note this form is not required unless the acquisition is valued (including all options) at greater than $22 million. This template is NOT applicable for actions using simplified acquisition procedures (FAR Part 13), Federal Supply Schedule orders (FAR 8.4) or task or delivery orders subject to fair opportunity (FAR 16.505).

Tailor all aspects of this template to the individual acquisition. Consult FAR Subpart 6.3 for guidance. An addendum may be added in case additional space is needed.

When this document is printed, theblue italic instructions are automatically deleted on the printed version.

Acquisition Title:

Agency:

Acquisition Year

Author and Title:

2. Description of Action:

Nature: New Requirement

Follow-on Requirement

Modificationto Existing Purchase Order/Contract Number:

Pricing: Firm-Fixed Price

Cost Time & Materials

Other:

Funds:

Other Funds:

OMA

Name of Proposed Contractor(s):

Street Address:

City, State, Zip:

3. Description of Services or Supplies:

Basis for Approval (FAR 6.303-1(d)): Individual Basis Class Basis

The total estimated value of the proposed action, including all options is $

As applicable, briefly describe the services or supplies required to meet the agency's needs, including make & model number where appropriate. Include quantities of supplies or period of performance for services. Provide information for any options included. If the action is a modification to an existing contract, distinguish clearly between the work covered by the original contract and the work to be obtained by the proposed modification.

(FY):

4. Authority and Rationale: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

Actionsother than simplified acquisition procedures(select only one and provide an explanation):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C.

3304(a)(1)

Explain why the intended contractor is the only responsible source who can provide the required supplies or services.

Discuss the unique capabilities, expertise, etc. that support the lack of competition/why no other type of supplies or servic es will satisfy agency requirements. Explain factors/unique qualifications such as proprietary data or exclusive licensing rights, if applicable. When competition is limited to items particular to one manufacturer, this justification must explain why the particular brand name, product, or feature is essential to the Government's requirements, and that market research indicates other companies' similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the agency's needs in accordance with FAR 11.105. If in connection with a follow-on contract for continued development or production of highly specialized equipment, detail the substantial duplication of cost or unacceptable delays.

FAR 6.302-2: Unusual and compelling urgency, 41 U.S.C. 3304(a)(2) If unusual and compelling urgency is the basis for the justification, explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/ serious injury to the mission of the requiringactivity or to the government, financial or otherwise, that will result if this justification is not approved. Describe impact of required delivery/performance date. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. Failure to plan for expiring funds is not a valid reason for citing this exception. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.

FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 3304(a)(5) Provide a citation to the statutory authorization and a brief description of its content, or identify the specified source or other agency.

Other (See FAR Subpart 6.3 for additional authority) Provide the authority and citation to the applicable section of FAR 6.3.

Provide a full explanation to justify use of the exception.

5. Agency Actions to Take or Remove Barriers That Led to Other Than Full and Open Competition (If applicable):

Describe the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration prior to any subsequent acquisition for the supplies of services is made. If no such actions have been taken, explain why.

6. Bridge Contracts:

For contract extensions or bridge contracts when a competitive follow-on is in the process of being developed, summarize history of current contract and explain the reasons for any delays in the acquisition. Include discussion of the milestones for the follow-on action; the milestones should be as efficient as possible. Discuss why it would be neither cost effective nor realistic to expect another contractor to perform during the brief interim period; include issues such as start -up costs, phase-in, transfer of GFP, recruitment and staffing, etc. If the action is because of a protest, provide a brief discussion of the protest including the date the protest was filed and the basis of the protest. Explain that the action will provide the minimum quantity or performance period.

7. Actions to Increase Competition:

Describe efforts made to compete the action, including whether a notice was or will be publicized as required by FAR Subpart

5.2 or which exception under FAR 5.202 applies. If a notice was publicized, discuss the number of written responses to the synopsis and the results of the assessment of the written responses. List sources, if any, that expressed, in writing, an interest in the acquisition. Provide rationale if interested sources were rejected. If applicable, state that no other sources have expressed interest, but all offers received shall be considered. Describe what actions will be taken to increase competition before subsequent acquisition of the supplies or services is required. Youmay state that an action is a one-time requirement, but if a similar requirement arises, every effort will be made to competeit to the maximum extent possible. If action is sole source because of proprietary data or licensing rights and there will be a continuing need for the requirement, there must be evidence that advanced planning has been initiated to overcome the barriers to competition, or there should be documentation to support an analysis that replacement costs/licensing purchase costs outweigh the benefits of competition. If the action is a contract extension or bridge, explain actions to compete the follow-on. If action is an urgent new requirement and a competitive follow-on is anticipated, explain that efforts are underway to facilitate a full and open competition.

8. Market Research:

with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of themarketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptablereason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If ac tion is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-on. See FAR 10.002(b)(2).

9. Procurement History:

Purchase order or contract number:

Was action competed? Yes No

If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

10. Additional Information to support the justification:

If applicable, explain why technical packages or specifications to facilitate competitionwere not developed or available;

describe actions taken to remedy the situation.

11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this J&A is accurate and complete.

Program Manager

Name:

Position Title:

Email address:

Phone:

Program Manager Supervisor (or one level above Program Manager)

Position Title:

Signature:

Date:

12. Fair and Reasonable Price/Cost Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.

Provide the basis for this determination, e.g., describe techniques to be used to determine fair and reasonable price (FAR Subpart 15.402), such as price analysis, cost analysis, cost realism. Per FAR Subpart 15.403-4(a)(1), the threshold for obtaining cost or pricing data is $750,000.

Name: Phone:

13. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

14. Legal Review:

All J&As greater than $68 million must have a legal reviewfrom the General Law Division of the Office of the General Counsel prior to sending it to the Department.

15. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million (value calculated including all options)):

I have reviewed this justification and find that it adequately supports other than full and open competition.

All J&As greater than $68 million must have a reviewfrom the Office of Small & Disadvantaged Business Utilization (OSDBU) prior to sending it to the Department. The OSDBU at their discretion may review any J&A.

16. Office of Small and Disadvantaged Business Utilization Review: (Required for contracts exceeding $68 million (value calculated including all options)):

Concur:

Non-Concur:

17. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million

18. Department Competition Advocate (Required for contracts exceeding $68 million (value calculated including all options)):

Jennifer Johnson (May 1, 2024 22:09 EDT)

(The belowapproval paragraph is required if the cumulative contract value, including all options, exceeds $68 million.)

19. HHS Senior Procurement Executive (SPE) Approval:

Based on the foregoing justification, I hereby approve other than full and open competition for the above stated procurement, subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

State supplies/servicesbeing procured:

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304:

Signature: HKBrisbon Date:

HKBrisbon (May 2, 2024 16:03 EDT)

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Completion Instructions: The Department of Health and Human Services (HHS) has established a standard template for the preparation of a J&A for Other Than Full and Open Competition. If this is an 8(a) set-aside, please note this form is not required unless the acquisition is valued (including all options) at greater than $22 million. This template is NOT applicable for actions using simplified acquisition procedures (FAR Part 13), Federal Supply Schedule orders (FAR 8.4) or task or delivery orders subject to fair opportunity (FAR 16.505).

Tailor all aspects of this template to the individual acquisition. Consult FAR Subpart 6.3 for guidance. An addendum may be added in case additional space is needed.

When this document is printed, theblue italic instructions are automatically deleted on the printed version.

Acquisition Title:

Agency:

Acquisition Year (FY):

Author and Title:

2. Description of Action:

Nature:

New Requirement

Follow-on Requirement

Modificationto Existing Purchase Order/Contract Number:

Pricing: Firm-Fixed Price

Cost Time& Materials

✔Other: Cost Reimbursement

Funds: OMA

Tobacco User Fee Funds ✔ Other Funds:

Name of Proposed Contractor(s): Alabama Department of Public Health, Arizona Department of Health Services, Arkansas Tobacco Control Board, Colorado Department of Public Health and Environment, Connecticut Office of Mental Health and Addiction Service, Guam Behavioral Health and Wellness Center, Hawaii Department of Health, Indiana University, Iowa Department of Commerce, Kansas Department of Revenue, Commonwealth of Kentucky, Public Protection Cabinet, Maine Department of Attorney General, Maryland Department of Health, Massachusetts Department of Public Health, Mississippi Attorney General’s Office, Missouri Department of Mental Health, New Hampshire Liquor Commission, Oklahoma State Health Department, Rhode Island Department of Behavioral Healthcare, Texas State University, and West Virginia Health and Human Resources

Street Address:

City, State, Zip:

3. Description of Services or Supplies:

Basis for Approval (FAR 6.303-1(d)): Individual Basis ✔Class Basis

The total estimated value of the proposed action, including all options is $ 130,820,841.26

As applicable, briefly describe the services or supplies required to meet the agency's needs, including make & model number where appropriate. Include quantities of supplies or period of performance for services. Provide information for any options included. If the action is a modification to an existing contract, distinguish clearly between the work covered by the original

Stacy Blake, Lead Regulatory Counsel

FDA

State Tobacco Retail Compliance Check Inspection Program https://www.acquisition.gov/far/part-13 https://www.acquisition.gov/far/part-8#FAR_Subpart_8_4 https://www.acquisition.gov/far/part-16#FAR_16_505 https://www.acquisition.gov/far/part-6#FAR_Subpart_6_3 https://www.acquisition.gov/far/part-6#FAR_6_303_1 contract and the work to be obtained by the proposed modification.

In accordance with the FD&C Act, the FDA will require retail inspection services during the term of this contract to include the following:

1. Facilitate the enforcement of the provisions amended by the Tobacco Control Act (TCA) and conduct inspections of retailers that sell and advertise any regulated tobacco products to determine compliance with the provisions cited in Section C and submit inspection results to FDA.

2. Collect, document, and preserve evidence of inspections and investigations.

3. Support FDA in any enforcement or judicial actions, including coordinating the drafting and execution of declarations by the Inspectors, arranging for their testimony if necessary, and furnishing evidence and narrative reports by the Inspectors and Underage Purchasers who participated in inspections.

4. Respond to inquiries by FDA concerning inspections, data, and other information associated with this program.

4. Authority and Rationale: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

Actionsother than simplified acquisition procedures(select only one and provide an explanation):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C.

3304(a)(1)

Explain why the intended contractor is the only responsible source who can provide the required supplies or s ervices.

Discuss the unique capabilities, expertise, etc. that support the lack of competition/why no other type of supplies or servic es will satisfy agency requirements. Explain factors/unique qualifications such as proprietary data or exclusive licensing rights, if applicable. When competition is limited to items particular to one manufacturer, this justification must explain why the particular brand name, product, or feature is essential to the Government's requirements, and that market research indicates other companies' similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the agency's needs in accordance with FAR 11.105. If in connection with a follow-on contract for continued development or production of highly specialized equipment, detail the substantial duplication of cost or unacceptable delays.

FAR 6.302-2: Unusual and compelling urgency, 41 U.S.C. 3304(a)(2) If unusual and compelling urgency is the basis for the justification, explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved. Describe impact of required delivery/performance date. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. Failure to plan for expiring funds is not a valid reason for citing this exception. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.

✔ FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 3304(a)(5) Provide a citation to the statutory authorization and a brief description of its content, or identify the specified source or other

The federal statute governing CTPs authority to conduct tobacco retail compliance check inspections is 21 U.S.C. 372. Specifically, 21 U.S.C.

372(a)(1)(B)(i) states "For a tobacco product, to the extent feasible, the Secretary shall contract with the States ... to carry out inspections of retailers within that State in connection with the enforcement of this chapter." This statute is CTP's legal basis for contracting with states where feasible.

The statue identifies FDA/CTP as having the authority to ensure retailers that sell and advertise regulated tobacco products comply with federal tobacco regulations. FDA conducts inspections of tobacco retailers with the support of state contracts. FDA receives the benefit of the information provided through compliance check inspections.

Contractors must possess legal authority to conduct inspections and investigations. Contractors must have trained personnel with inspectional experience necessary to assess the conformance of an establishment with the federal law. Contractors must have demonstrated experience with regulatory procedures.

Per the Tobacco Control Act, Public Law 111-31, Section 103(g)(2), the FDA is mandated to contract with states "to the extent feasible."

Only governmental organizations have the unique qualification to perform this kind of activity. Competition within states does not exist for https://www.acquisition.gov/far/part-6#FAR_Subpart_6_3 https://www.acquisition.gov/far/part-6#FAR_6_302_1 https://www.acquisition.gov/far/part-11#FAR_11_105 this program. Within any state, its legislature designates the governmental organizations which have the authority and resources to accomplish a program. The prospective contractors for this solicitation are those designated state organizations.

Other (See FAR Subpart 6.3 for additional authority) Provide the authority and citation to the applicable section of FAR 6.3.

Provide a full explanation to justify use of the exception.

5. Agency Actions to Take or Remove Barriers That Led to Other Than Full and Open Competition (If applicable):

Describe the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration prior to any subsequent acquisition for the supplies of services is made. If no such actions have been taken, explain why.

In accordance with 41 U.S.C 3304 (a)(5) "An executive agency may use procedures other than competitive procedures only when subject to section 3105 of this title, a statute expressly authorizes or requires that the procurement be made through another executive agency or from a specified source, or the agency's need is for a brand-name commercial product for authorized resale. No such actions have been taken to remove barriers due to the statue authority of 41.U.S.C 3304(a) (5). FDA must procure with the states/territories however when the states are unable to provide the services FDA has awarded competitive contracts to contractors in those states.

6. Bridge Contracts:

For contract extensions or bridge contracts when a competitive follow-on is in the process of being developed, summarize history of current contract and explain the reasons for any delays in the acquisition. Include discussion of the milestones for the follow-on action; the milestones should be as efficient as possible. Discuss why it would be neither cost effective nor realistic to expect another contractor to perform during the brief interim period; include issues such as start-up costs, phase-in, transfer of GFP, recruitment and staffing, etc. If the action is because of a protest, provide a brief discussion of the protest including the date the protest was filed and the basis of the protest. Explain that the action will provide the minimum quant ity or performance period.

Not Applicable

7. Actionsto Increase Competition:

Describe efforts made to compete the action, including whether a notice was or will be publicized as required by FAR Subpart

5.2 or which exception under FAR 5.202 applies. If a notice was publicized, discuss the number of written responses to the synopsis and the results of the assessment of the written responses. List sources, if any, that expressed, in writing, an interest in the acquisition. Provide rationale if interested sources were rejected. If applicable, state that no other sources have expressed interest, but all offers received shall be considered. Describe what actions will be taken to increase competition before subsequent acquisitionof the supplies or services is required. Youmay state that an action is a one-time requirement, but if a similar requirement arises, every effort will be made to competeit to the maximum extent possible. If action is sole source because of proprietary data or licensing rights and there will be a continuing need for the requirement, there must be evidence that advanced planning has been initiated to overcome the barriers to competition, or there should be documentation to support an analysis that replacement costs/licensing purchase costs outweigh the benefits of competition. If the action is a contract extension or bridge, explain actions to compete the follow-on. If action is an urgent new requirement and a competitive follow-on is anticipated, explain that efforts are underway to facilitate a full and open competition.

CTP's statutory duty to contract with states/territories prompts a CICA exception, so CTP will not pursue competitive procurements in jurisdictions where the state/territory government expresses a desire to conduct tobacco retailer inspections. 41 U.S.C. 3304(a)(5). In these instances, CTP will award sole-source contracts with the state or territorial entity designated to perform inspections within that jurisdiction.

For the states/ territories that do not want to or are incapable of performing inspections, CTP will issue a task order for a third party contract to perform inspections in those states/territories.

8. Market Research:

Describe the extent of the market research conducted to identify all qualified sources and the results thereof. “Market Research” is defined as those attempts you made to ascertain whether other qualified sources exist, and can include contact with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of themarketplace may consist of written, electronic (i.e. email) telephonic, or world https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_5_202 wide web inquiries. Lack of advanced planning is not an acceptablereason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If ac tion is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-on. See FAR 10.002(b)(2).

FDA issued a Request for Information (RFI) on November 22, 2023 to determine interest in contracting with the Federal Government.

Questions were posed to the state jurisdictions to understand their capacity to perform the required tasks of the contract, to ask whether any aspects of the requirement would present difficulties within a particular jurisdiction, and the nature of any subcontracting relationships might pursue to perform the requirement.

9. Procurement History:

Purchase order or contract number: AL #75F40120C00143, AZ #75F40120C00117, AR #75F40120C00144, CO #75F40120C00145, CT #75F40120C00149, GU #75F40120C00049, HI #75F40120C00046, IN #75F40120C00066, IA #75F40120C00119, KS #75F40120C00110, KY #75F40120C00146, ME #75F40120C00051, MD #75F40120C00107, MA #75F40120C00142, MS #75F40120C00106, MO #75F40120C00121, NH #75F40120C00048, OK #75F40120C00147, RI

#75F40120C00050, TX #75F40120C00130, WV #75F40120C00103

Was action competed? Yes

No ✔

If action was not competed, state the citedauthority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

The TCA authorizes the FDA to carry out inspections of retail outlets that sell tobacco products to determine compliance with the Federal Food and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (TCA), and its implementing regulations found at 21.C.F.R Part 1140. The new IDIQ contracts with Alabama, Arizona, Arkansas, Colorado, Connecticut, Guam, Hawaii, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Mississippi, Missouri, New Hampshire, Oklahoma, Rhode Island, Texas, and West Virginia will have a period of performance comprised of 5 years. FDA currently has contracts in place for the States that are expiring on September 29, 2024 and seeking new contracts to continue in FY24.

10. Additional Information to support the justification:

If applicable, explain why technical packages or specifications to facilitate competitionwere not developed or available;

describe actions taken to remedy the situation.

Due to statue 21 U.S.C. 372(a)(1)(B)(i), the acquisition will be limited to governmental agencies within the State of Alabama, State of Arizona, State of Arkansas, State of Colorado, State of Connecticut, Territory of Guam, State of Hawaii, State of Indiana, State of Iowa, State of Kansas, State of Kentucky, State of Maine, State of Maryland, State of Massachusetts, State of Mississippi, State of Missouri, State of New Hampshire, State of Oklahoma, State of Rhode Island, State of Texas, and State of West Virginia.

11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this J&A is accurate and complete.

Program Manager

Name: Thomas Lawson

Position Title: Regulatory Counsel

Email address:

thomas.lawson@fda.hhs.gov

Phone: 240-402-4254

Program Manager Supervisor (or one level above Program Manager)

Name: Carlene Farris Clarke

Position Title: Supervisory Regulatory Counsel https://www.acquisition.gov/far/part-10#FAR_10_002 mailto:thomas.lawson@fda.hhs.gov carlene.farrisclarke@fda.hhs.gov

Date: 11/30/2023

12. Fair and Reasonable Price/Cost Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.

Provide the basis for this determination, e.g., describe techniques to be used to determine fair and reasonable price (FAR Subpart 15.402), such as price analysis, cost analysis, cost realism. Per FAR Subpart 15.403-4(a)(1), the threshold for obtaining cost or pricing data is $750,000.

In accordance with 15.404-1, a cost analysis will be performed to evaluate the reasonableness of all the individual cost elements .

Certified cost or pricing data will be requested and a determination of cost reasonableness will be performed.

Name: Madeline Bryant Phone: 2404027611

13. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Name: Madeline Bryant Phone: 2404027611

Signature: Date:

mailto:carlene.farrisclarke@fda.hhs.gov https://www.acquisition.gov/far/part-15#FAR_15_402 https://www.acquisition.gov/far/part-15#FAR_15_402 https://www.acquisition.gov/far/part-15#FAR_15_403_4

14. Legal Review:

All J&As greater than $68 million must have a legal reviewfrom the General Law Division of the Office of the General Counsel prior to sending it to the Department.

OGC GLD has reviewed and find the J&A legally sufficient.

15. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million (value calculated including all options)):

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name: Phone: 240 402 8166

Signature: Date: 3/8/2024

All J&As greater than $68 million must have a reviewfrom the Office of Small & Disadvantaged Business Utilization (OSDBU) prior to sending it to the Department. The OSDBU at their discretion may review any J&A.

16. Office of Small and Disadvantaged Business Utilization Review: (Required for contracts exceeding $68 million

Signature: Date:

17. OPDIV HCA Approval (Required for proposedcontract over $13.5 million but not exceeding $68 million (value calculated including all options)):

Name: Phone: 240-402-7584

Signature: Date: 03-08-2024

18. Department Competition Advocate (Requiredfor contractsexceeding $68 million (value calculated including all options)):

Name: Jennifer Johnson Phone:

(The belowapproval paragraph is required if the cumulative contract value, including all options, exceeds $68 million.)

19. HHS Senior Procurement Executive (SPE) Approval:

Based on the foregoing justification, I hereby approve other than full and open competition for the above stated procurement, subject to theavailability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

State supplies/servicesbeing procured:

The contractor shall provide the following services:

1. Facilitate the enforcement of the provisions with respect to tobacco retailers.

2. Conduct inspections of retailers that sell and advertise any regulated tobacco products to determine compliance with the provisions and submit inspection results to FDA.

3. Collect, document, and preserve evidence of inspections and investigations.

4. Support FDA in any enforcement or judicial actions, including coordinating the drafting and execution of declarations by the Inspectors, arranging for their testimony if necessary, and furnishing evidence and narrative reports by the Inspectors and Underage Purchasers who participated in inspections.

5. Respond to inquiries by FDA concerning inspections, data, and other information associated with this program.

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304:

FAR 6.302-5: Authorized or Required by Stature, 41.U.S.C. 3304(A)(5) “When noncompetitive procedure may be used —An executive agency may use procedures other than competitive procedures only when—subject to section 3105 of this title, a statute expressly authorizes or requires that the procurement be made through another executive agency or from a specified source, or the agency’s need is for a brand-name commercial product for authorized resale Tobacco Control Act, Public Law 111-31, Section 103(g)(2)(i) For a tobacco product, to the extent feasible, the Secretary shall contract with the States in accordance with this paragraph to carry out inspections of retailers within that State in connection with the enforcement of this Act.

Name: H. Katrina Brisbon Phone: