A7 - J and A - Data Purchasing Project - NAVIPPRO - PR 43716.pdf

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Data Purchasing Project (Navippro)
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00HCUHGC-2020-43716
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Template for 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, the blue italic instructions are automatically deleted on the printed version.

JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION

2. Description of Action:

Nature:

Pricing:

Funds:

3. Description of Services or Supplies:

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

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.

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.

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

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 services 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. May not Exceed one year, including all options, unless the head of the agency (Secretary of HHS) determines that exceptional circumstances apply.

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.

Provide a citation to the statutory authorization and a brief description of its content, or identify the specified source or other agency.

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. You may state that an action is a one-time requirement, but if a similar requirement arises, every effort will be made to compete it 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:

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 the marketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptable reason 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 action 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:

Was action competed?

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 competition were 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) Name:

Position Title:

Email address:

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:

Signature:

Date:

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 herin describe have otherwise been authorized for acquisition.

Name:

Phone:

Signature:

Date:

14. Legal Review:

All J&As greater than $68 million must have a legal review from 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.

Name:

Phone:

Signature:

Date:

16. Office of Small and Disadvantaged Business Utilization:

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

Name:

Phone:

Signature:

Date:

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

Name:

Phone:

Signature:

Date:

18. Department Competition Advocate:

Concur:

Non-Concur:

Name:

Phone:

Signature:

Date:

(The below approval 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/services being procured:

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

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

Phone:

Signature:

Date:

11.0.0.20130303.1.892433.887364 Justification & Approval - Other Than Full and Open Competition Health and Human Services Justification & Approval - Other Than Full and Open Competition

AcquisitionTitle: Data Purchasing Project to Better Understand Substance Use Patterns among People Being Screened for or Entering Substance Abuse Treatment
Agency: CDC
NIHDrop:
PSCDrop:
PSCOther:
AcqusitionYear: 2020
Author: Terry W. Davis, EdD, Public Health Advisor, COR II
CheckBox4: 1
CheckBox5: 0
CheckBox1: 0
Purchase order/contract number:
CheckBox8: 1
CheckBox7: 0
CheckBox6: 0
CheckBox9: 0
Agency Actions to Take or Remove Barriers That Led to Fair Opportunity Exception (If applicable): If the required data becomes available by other sources, the CDC will consider competition.
CheckBox10: 0
CheckBox11: 1
Other funds: 9390CJZ 5643-11-11-01
TextField5: Inflexxion
TextField5: 3070 Bristol St. Suite 350
TextField5: Costa Mesa, CA 92626
CheckBox2: 1
CheckBox3: 0
TextField7: 3,000,000
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 basic order and the work to be obtained by the proposed modification.: Purchase proprietary data source for in-depth information on substance use patterns, including substances used, routes of use, demographic, social, legal, medical, psychiatric, and employment data on individuals being screened for or entering substance abuse treatment.
CheckBox12: 1
State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: Although current surveillance systems such as the National Survey on Drug Use and Health (NSDUH) and the Treatment Episode Data Set (TEDS) do provide essential data on substance use patterns, the NAVIPPRO system provides data that is not well-captured in either of these data sources or other Federal data systems. For example, NSDUH, as a household survey, is quite limited in its ability to examine injection drug use trends due to the low prevalence of this behavior in the overall population. Thus, NSDUH is limited in its ability to examine injection drug use for various drugs by demographic groups due to small numbers and suppression criteria and reliability of estimates. Further, NSDUH only captures data on injection of a limited set of drugs. NSDUH is also limited in the legal consequences and psychiatric data it captures. TEDS is the Federal dataset most similar to the NAVIPPRO system but also suffers from important limitations that do not apply to the NAVIPPRO system. For example, TEDS is limited in the number of substances that are reported by states to SAMHSA, i.e., only the primary, secondary, and tertiary substances of abuse at treatment admission are recorded. This limits the ability of policymakers to understand patterns of poly-substance use which is the rule rather than exception. In addition, although TEDS does capture route of use and some demographic, socioeconomic, and medical/mental health data, many of these variables have a high percentage of missing values which limit their utility, representativeness, and generalizability. In many cases, researchers do not use these variables due to high numbers of missing values. The NAVIPPRO system stands to compliment current Federal systems by providing data on the full range of substances used as well as the routes of use for each of these substances along with detailed demographic data, social, legal, medical, psychiatric, and employment data using a validated assessment tool, the Addiction Severity Index (ASI). Further, the ASI is designed to calculate a severity score for each of the 7 domains of the ASI which enables robust and informative analyses between different substances used and combinations of substances used and other health, social, legal, and psychiatric domains. These analyses are not always possible with the NSDUH data due to limitations in case counts or not collecting relevant data; similarly, they are not always possible in TEDS due to missing values and the limitation of only capturing 3 substances of abuse. NAVIPPRO also captures data on specific brand name prescription drugs which neither the NSDUH or TEDS capture. In addition, because NAVIPPRO represents a census of the data collected, it does not suffer from the same analytic limitations of a sample-based surveillance system such as the NSDUH. In addition to Federal data systems, private proprietary data systems also capture some, but not all, of the information included in the NAVIPPRO. For example, the RADARS systems, and more specifically, the treatment center data within the RADARS system, does capture information on route of use among certain people coming in to treatment, but the system is designed to only capture individuals with an underlying opioid use disorder. Thus, the RADARS system does not meet our requirements since we are specifically interested in capturing data on individuals entering or being screened for treatment regardless of whether they have an opioid use disorder. We require the data system to provide information on individuals who have other substance use disorders with or without an opioid use disorder. In addition, we require a data system that uses a validated assessment instrument such as the ASI. Our desire to purchase these data is based on an assessment of the current Federal and proprietary surveillance systems and their gaps. The NAVIPPRO system meets our specific requirements and that other proprietary systems do not.
State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: N/A
State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: N/A
State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: N/A
State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: N/A
State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: N/A
State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: In future years, if any company or organization can provide the needed data, we would make every effort to compete it to the maximum extent possible.
State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: Market Research was conducted by exploring other data sets and discussing with knowledgeable experts. No other company or organization has this data. These analyses are not always possible with the NSDUH data due to limitations in case counts or not collecting relevant data; similarly, they are not always possible in TEDS due to missing values and the limitation of only capturing 3 substances of abuse, does capture information on route of use among certain people coming in to treatment, but the system is designed to only capture individuals with an underlying opioid use disorder. Please see additioanl rationale in the authority and rationale section. We did do market research by talking with other federal agencies that have used NAVIPPRO data and is determined that the price for this task order demonstrates parity in cost. Pricing for this data acquisition is below market retail cost.
State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements.

10 U.S.C. 2304(c)(1): The property or services needed by the agency are available from only one responsible source or only from a limited number of responsible sources.

41 U.S.C. 523(c)(1): No other type of property or services will satisfy the needs of the agency

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: Price analysis will be used to determine the price to be fair and reasonable. Negotiations will be conducted to ensure the final price is at or below standard commercial pricing.
CheckBox13: 0
CheckBox14: 0
CheckBox15: 0
TextField9: 75D301-19-C-06863
CheckBox16: 0
CheckBox17: 1
Program Manager name: Terry W. Davis, EdD
Program Manager position title: Public Health Advisor, COR II
Program Manager email address: ddu8@cdc.gov
Program Manager phone: 770-488-3940
Program Manager Supervisor name: Jan L. Losby, PhD
Program Manager Supervisor position title: Branch Chief, HSRB
Program Manager Supervisor email address: kfy9@cdc.gov
HHS Senior Procurement Executive (SPE) signature:
Program Manager Supervisor date: 3-12-2020
Contract Officer's Approval name: H. Dale Bish
Contract Officer's Approval name: H. Dale Bish
HHS Senior Procurement Executive (SPE) phone: 404-498-1312
HHS Senior Procurement Executive (SPE) phone: 404-498-1312
HHS Senior Procurement Executive (SPE) phone: 404-639-7291
HHS Senior Procurement Executive (SPE) phone: 770.488.2628
Contract Officer's Approval date: 2020-05-18
Contract Officer's Approval date: 2020-05-18
HHS Senior Procurement Executive (SPE) name: Sherry Smallwood
HHS Senior Procurement Executive (SPE) name: Jeffrey L. Napier
DateField6: 2020-06-22
Office of Small Business date:
OPDIV HCA date: 2020-06-19
Concur with Acquisition: 0
Non-Concur with Acquisition: 0
HHS Senior Procurement Executive (SPE) date:
State supplies/services being procured:

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