JOFOC_FDA_NAS_Opioid_Study.pdf

J&A under FAR Subpart 6.3 - Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. Department of Health and

Human Services/Program Support Center/Acquisition Management Services

b. Requiring activity. Office of the Commissioner, Office of Medical Products and Tobacco

c. Requiring Activity Point of Contact (POC) information.

Trudy Lilly, Contracting Officer Representative Trudy.lilly@fda.hhs.gov 10903 New Hampshire Avenue Bld. 1, Room 2306 Silver Spring, MD 20904

(301) 796-1371

Anna Fine, Lead Technical Representative Anna.fine@fda.hhs.gov

(301) 796-8471

Kathleen Davies, Lead Technical Representative Kathleen.davies@fda.hhs.gov

(301) 796-2205

2. Nature and/or description of the action being approved.

Acquisition purpose and objectives.

As part of FDA’s focus on appropriate prescribing of opioid analgesics, this Statement of Work (SOW) seeks to obtain the independent, objective perspectives and expert services of the National Academies of Sciences, Engineering, and Medicine (National Academies). An ad hoc committee will develop a framework to evaluate existing clinical practice guidelines for prescribing opioid analgesics for medical conditions or surgical procedures associated with acute pain and recommend for which new evidence-based guidelines should be developed, and recommend a future plan/research agenda to inform and enable specialty organizations to develop and disseminate evidence-based clinical practice guidelines for prescribing opioid analgesics to treat acute pain where prescribing is warranted.

Project background.

FDA is seeking to work with a broad range of stakeholders, including medical professional societies, to evaluate existing clinical practice guidelines on the appropriate prescribing of opioid analgesics for acute pain associated with different medical conditions and surgical procedures. Key objectives of this effort will be to:

• Develop a framework that will derive and spur the generation of evidence -based clinical practice guidelines for appropriate prescribing of opioid analgesic products for specific medical conditions or surgical procedures associated with acute pain;

• Identify and prioritize specific surgical procedures and medical conditions associated with acute pain for which opioid analgesics are commonly prescribed and considered clinically necessary, (i.e., develop a diversified list not exceeding 50, of specific surgical procedures (e.g. cholecystectomy) and medical conditions (e.g. low back pain) where evidence-based clinical practice guidelines would help inform prescribing practices).

• Based on the list of identified surgical procedures and medical conditions, evaluate the available clinical practice guidelines for opioid analgesics prescribing to determine which specific surgical procedures or medical conditions have clinical practice guidelines.

For any surgical procedure or medical condition listed above for which no prescribing guidelines exist or for which evidence is required to support existing clinical practice guidelines, create a plan/research paper (not to exceed 10 each of surgical procedure or medical condition) that indicates deficiencies and includes what additional information is required to bring the clinical guidelines up to the standards indicated in the developed framework.

a. Approach. HHS will issue a purchase order from the basic ordering agreement (BOA) awarded to:

Vendor: National Academy of Sciences Agreement #: TBD Period of Performance: 16 months Agreement Amount: $ 1,096,504.00 (includes PSC’s 2.5% fee

Not Applicable Competition Type: BOA Sole Source

The estimated base value of this proposed action is $1,096,504.00 The anticipated period of performance for this task order is 16 months from the time of the award. The total NTE amount for NAS billing is $ $1,069,760.00.

However, the total IGCE is $1,096,504 which includes PSC admin fees.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. The National Academies of Sciences: Develop Evidence Base to Inform Opioid Prescribing

b. Project description. As part of FDA’s continued focus on building a national governance system for evidence generation, this requirement seeks to obtain the independent, objective viewpoint and expert services of NAS to conduct a workshop series and publish a final capstone report.

An ad-hoc committee of the NAS shall plan and conduct a three-part workshop series to be held over the course of a two-year period.

Requirement type.

Research & development (R&D) R & D support services xSupport services (non-R&D)

Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify):

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive- fee):

Cost-plus-fixed-fee xOther cost reimbursement: Cost with no fee in accordance with BOA, NTE $1,069,760 Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements):

Other (specify):

Completion Form Term form

Acquisition identification number. 18-233-SOL-00692

c. Total estimated dollar value and performance/delivery period. A cost reimbursable (non-severable) contract is planned with a base period of performance of 16 months from the time of the award.

The estimated base value of this proposed action is $1,069,760

4. Identification of the statutory authority permitting other than full and open competition.

Federal Acquisition Regulation (FAR):

X 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

6.302-2 Unusual and compelling urgency. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(2) or 41 U.S.C. 3304(a)(2).

6.302-3 Industrial mobilization; engineering, developmental, or research capability; or expert services. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(3) or 41 U.S.C. 3304(a)(3).

6.302-4 International agreement. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C.

2304(c)(4) or 41 U.S.C. 3304(a)(4).

6.302-5 Authorized or required by statute. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(5) or 41 U.S.C. 3304(a)(5).

6.302-6 National security. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(6) or 41 U.S.C. 3304(a)(6).

6.302-7 Public interest. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(7) or 41 U.S.C. 3304(a)(7).

13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C.

1903.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

National Academies of Sciences - Engineering - Medicine 500 Fifth Street, N.W. KECK 1051 Washington, D.C. 20001

b. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

For more than 150 years, The National Academies of Sciences, Engineering, and Medicine (NAS) has been advising the nation on issues of science, technology and medicine. This organization was established through a Congressional charter, signed in 1863 by President Lincoln.

To date, it is the only non-profit institution commissioned to enlist foremost scientists, engineers, health professionals and other specialized disciplines to address scientific and technical issues, like the opioids crisis.

NAS is a private, nonprofit institute that provides expert advice on some of the most pressing challenges facing the nation and the world. NAS is the only organization capable of providing a highly-specialized, fair and impartial study of the opioids crisis happening today. Based on its unique staffing model and ability to attract renown experts, domestically and internationally, this organization demonstrates a strong ability to fulfill all the requirements set forth in this task order. In addition, its non-profit status makes this a good candidate for a neutral and third-party study.

Based in its long-standing relationship with federal agencies, NAS is identified as the best candidate to fulfill the requirements of this highly visible and politically charged study. NAS continues to maintain its reputation of providing independent, objective and nonpartisan advice, while maintaining exceptional performance with delivering valuable and credible reports.

Noncompetitive awards to NAS were authorized by the President in Executive Order (E.O.) 12832 on January 19, 1993, stating "When a department or agency of the executive branch of the Government determines that the Academy, because of its unique qualifications, is the only source that can provide the measure of expertise, independence, objectivity, and audience acceptance necessary to meet the department's or agency's program requirements, acquisition of services by the

Academy may be obtained on a noncompetitive basis if otherwise in accordance with applicable law and regulations."

The NAS is an esteemed, independent, and objective institution that convenes experts in science and technology and incorporates diverse points of view in all its activities. In addition, it is a membership-based, self-governing activity comprising leaders from FDA and the NIH, academia, foundations and professional organizations, patient and disease advocacy organizations, and the pharmaceutical industry.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

A notice of intent to sole source award to NAS was posted in accordance with FAR 5.2 on July 25, 2018 citing the authority – 6.302-1. The notice closed on August 9, 2018. There were no responses from any other interested parties.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

A detailed review of the Contractor’s proposal was performed by technical and procurement personnel to assure that the negotiated Purchase Order price was fair and reasonable in accordance with the terms and conditions of the basic order agreement – contract number: 18-233-SOL-00692.

An evaluation of the business and technical proposal determined that NAS’ pricing proposal was consistent with the IGCE; therefore, the FDA deems the cost proposal reasonable. The IGCE was developed through market research analysis, like analogous estimate reviews from prior contracts.

Specifically, section G.2 MINIMUM COST INFORMATION FOR COST REIMBURSEMENT CONTRACTS states:

The Contractor shall provide a summary page showing the cost breakdown by element. The Contractor shall also provide a cost breakdown by element by task. The following minimum information in support of costs submitted:

a. Direct Labor - include all persons, listing the person=s name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

b. Fringe Costs - show rate, base and total amount;

c. Overhead or Indirect Costs - show rate, base and total amount;

d. Consultants - include the name, number of days or hours worked, daily or hourly rate, a total amount per consultant and a total amount for this category;

e. Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs include ground transportation shown separately and the per diem costs. Other travel costs shall also be listed. A total amount for this category shall be provided;

f. Subcontractors - include, for each subcontractor, the same data as is being provided for the prime Contractor. A total amount for this category shall be provided;

g. Data Processing - include all non-labor costs, i.e., computer time, equipment purchase, lease or rental, data tapes. A total amount for this category shall be provided;

h. Other Direct Costs - include a listing of all other direct charges to the contract,

i. e., office supplies, telephone, equipment rental, duplication, postage;

i. G&A- show rate, base and total; and

j. Fee - show rate, base and total.

Also, the Contractor is required to comply with Federal Acquisition Regulation clause 52.215-19 Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data (July 2005)

Finally, no audit will be performed.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Knowledgeable acquisition and program officials in Government and industry were contacted regarding market capabilities. Also, literature published by qualified organizations was reviewed. No other qualified firms able to fulfill this requirement were found.

9. Any other facts supporting the use of other than full and open competition.

NAS provides a neutral and impartial venue for discussing complex and forward thinking controversial topics of discussions. FDA has worked with NAS on prior contracting efforts and their performance was exceptional.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. To date, no other sources have expressed an interest, in writing, in the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services. This effort will not result in additional follow-on work in the future. This continuous effort for 16 months from the time of the award. Tis timeframe will conclude the specified program activities for this particular effort.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Requiring Activity

POC

Trudy Lilly, Senior Policy Coordinator

7/6/18

POC Immediate Supervisor

Dr. Nina Hunter, Deputy Director for Medical Products

7/6/18

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

Jared Van Buskirk, Branch Chief, Acquisition Management Services

14. Competition Advocate and Head of the Procuring Activity approval.

Official Name & Title Signature Date

Competition Advocate and

Head of the Procuring Activity

Patrick A. Joy, Head of the Contracting Activity, Acquisition Management Services, Program Support Center

Trudy Lilly -S Digitally signed by Trudy Lilly -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Trudy Lilly -S, 0.9.2342.19200300.100.1.1=2000051579 Date: 2018.08.20 14:39:31 -04'00'

Anna M.

Fine -S

Digitally signed by Anna M. Fine -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Anna M. Fine -S, 0.9.2342.19200300.100.1.1=1300432 Date: 2018.08.20 14:43:26 -04'00'

Samuel C. Layton

08/21/2018

Digitally signed by Samuel C. Layton -S DN: c=US, o=U.S. Government, ou=HHS, ou=PSC, ou=People, 0.9.2342.19200300.100.1.1=20021898 48, cn=Samuel C. Layton -S Date: 2018.08.21 07:20:29 -06'00'