Justification and Approval.pdf

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Justification & Approval

FAR 6.302-1 Only One Responsible Source

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

DHHS/FDA/CBER

b. Sponsoring organization.

FDA/CBER

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name: Michael T. Fischer

ii. Mailing address: 10903 New Hampshire Ave, Bldg 71 STE 600

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

The purpose for this contract is to provide epidemiologic and analytical support to CBER’s Office of Biostatistics and Epidemiology to conduct surveillance activities for the safety and effectiveness of biologics including, vaccines, and to preserve public health by responding to pandemic and other emerging infectious disease threats to public health.

a. Acquisition purpose and objectives.

The objectives of this contract are to:

1. Provide support to FDA/CBER active surveillance activities by providing study protocols to facilitate the implementation of surveillance activities and epidemiologic studies that promote FDA/CBER’s mission to assure the safety and effectiveness of biologics including, vaccines, and to address FDA/CBER’s pandemic preparedness priorities.

2. Provide scientific and technical support in surveillance activities, including study implementation and study interpretation, to address FDA regulatory needs

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b. Project background.

See attached SOW

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

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biologic products, medical devices, tobacco products, our nation’s food supply, cosmetics and products that emit radiation. The FDA is also responsible for advancing public health by helping to speed innovations that make medicines, devices, products, and foods more effective, safer, and affordable. Moreover, the FDA provides the public with accurate, science-based information needed to consume medicines and foods to improve their health. As part of its mission, the FDA conducts monitoring of the safety of regulated products.

In response to the FDA Amendments Act of 2007 (FDAAA 2007), CBER established the CBER Surveillance Program (CSP) and built a national electronic data system for monitoring the safety and effectiveness of CBER-regulated biologic products, with the goal to build an active postmarket risk identification and analysis system.

CBER’s Office of Biostatistics and Epidemiology (OBE) initiated postmarket safety studies working collaboratively with federal partners such as the Veterans Health Administration, Indian Health Services, and Centers for Medicare and Medicaid Services (CMS). OBE has conducted numerous epidemiological studies with private sector partners as well. In 2016, CBER funded a study using artificial intelligence, natural language processing, and advanced analytics to more efficiently analyze and review adverse event reports and trends in reports to support and enhance our postmarket safety surveillance work. In October 2017, CBER launched the Biologics Effectiveness and Safety (BEST) program, in an expansion of CSP. The primary goals of CSP is to create and utilize an active surveillance system for the safety and effectiveness of CBER-regulated products, including vaccines and blood, and to be prepared for pandemics and respond to the occurrence of emerging infectious diseases, such as coronavirus 2019 (COVID-19) and influenza.

a. Project title.

CBER Protocol Development and Epidemiology Support

b. Project Description.

See attached SOW

Requirement type.

Research & Development (R&D)

R&D support services

Support services (non-R&D)

☐ Supplies/equipment

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Information Technology (IT)

☐ Construction

☐ Architect-Engineer (A&E) services

☐ Design-build

☐ Other:

Type of action.

New requirement

Follow-on

Other:

Proposed contract/order type.

Firm-fixed-price

Other fixed-price:

Cost-plus-fixed-fee

Other cost reimbursement:

Time and materials (Labor Hour)

Indefinite delivery:

Other:

Completion Form

Term Form

Acquisition identification number.

OBE-21-C-4112

c. Total estimated dollar value and performance/delivery period.

$980,180.00 Total Award Amount.

07/15/2021 to 07/14/2021.

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

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).

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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).

RTI Health Solutions Research Triangle Park, North Carolina, USA P.O. Box 12194 3040 East Cornwallis Road Research Triangle Park, NC 27709-2194

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

This is a sole source acquisition.

RTI has leveraged their unique advanced epidemiology capacity to deliver study protocols for COVID-19 vaccines and therapeutics for other international regulators. Specifically, RTI HS has developed and finalized study protocols of similar COVID-19 vaccine studies for international regulators, e.g., European Medicines Agency and provided high-quality study protocols in time-sensitive manner.

RTI has the advanced pharmacoepidemiology expertise needed to fully understand the complexity of real world data sources in the FDA/CBER OBE surveillance system and to produce work products, including study protocols, to generate real world evidence to support FDA/CBER/OBE regulatory decisions in monitoring the safety and effectiveness of biologics including COVID-19 vaccines.

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RTI has a cadre of specialized experience pooled from their highly-respected, academically-trained, credentialed researchers who have steep experience in applied the appropriate research methodologies needed by FDA. These RTI staff include researchers who have worked with FDA Sentinel Initiative on developing study protocols and executing surveillance studies with Harvard Pilgrim and has the unique experience of delivering work products of this complexity that meets FDA regulatory needs. RTI demonstrated epidemiology expertise is evidenced in a collection of their staff who held leadership positions in the professional society for epidemiologists, including in the roles of Fellow and Past President of the International Society for Pharmacoepidemiology and have either held or currently are in academic positions at highly respected departments of epidemiology including University of North Carolina School of Public Health and Harvard University.

Timely delivery of high-quality study protocols to execute FDA/CBER surveillance studies is crucial in FDA’s COVID-19 pandemic response.

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.

Upon review of market research results, the Contracting Officer – due to the urgent and compelling nature of the requirement – determined it to be in the Agency’s best interests not to solicit offers from any additional sources upon the condition that a fair and reasonable price can be negotiated with the prospective responsible awardee.

A Contract Opportunities notice will not be publicized in beta.SAM.gov, as required by FAR Subpart

5.2 under the exception provided at FAR 5.202(a)(2): The proposed contract action is made under the conditions described in 6.302-2(or, for purchases conducted using simplified acquisition procedures, if unusual and compelling urgency precludes competition to the maximum extent practicable) and the Government would be seriously injured if the agency complies with the time periods specified in 5.203.

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

The Contracting Officer will use appropriate and available information to review proposed prices and determine that they are fair and reasonable, and such documentation shall be included in the contract file. The contracting officer will review the offerors’ published commercial price, including prices list on various government-wide acquisition vehicles and other sites, such as pricing data contained in the GSA Acquisition Gateway Pricing Portal. The Contracting Officer will also request other cost data, and explanations regarding market conditions, from the offeror, in the event that offerors submit prices that exceed published commercial prices. Other information that may be used includes Independent Government Cost Estimates (IGCE), historical information, contractor’s invoice payments and commercial pricing that have been determined to be fair and reasonable.

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Actions taken under the authority of this class justification shall include a documentation of the price/cost analysis conducted and that the proposed price is fair and reasonable.

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.

RTI has a contract with a non-profit international group for the same support services,

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

In response to the COVID-19 pandemic, CBER is in midst of rapid execution of multiple studies and development of planned studies to monitor the safety and effectiveness of COVID-19 vaccines after authorization or licensure. This requires development of various study protocols, public posting of the protocols for transparency and support in study implementation. To date, CBER OBE has posted 2 study protocols for vaccine safety and has 2 currently in development with BEST Initiative contractors.

There are at least 3 additional study protocols for vaccine safety and effectiveness that require urgent attention for protocol development to initiate surveillance of COVID-19 vaccines. The services of a contractor with strong and demonstrated pharmacoepidemiology expertise is needed to move CBER OBE’s surveillance activities forward to respond to the COVID-19 pandemic in a timely manner.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

N/A

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.

Ongoing market research will continue to assess whether other sources become available. Any subsequent acquisitions will undergo thorough market research before any decision is made about available sources.

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.

Signature:____________________________________

Jason A.

Claeys -S

Digitally signed by Jason A. Claeys -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2001864387, cn=Jason A. Claeys -S Date: 2021.07.02 16:10:13 -04'00'

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Jason Claeys COR/Requiring Activity POC

Signature:____________________________________

Brian Hively COR/POC Immediate Supervisor

Michael Fischer Head of the Sponsoring Program Office

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.

Terry L. Frederick Contracting Officer

Michael T. Fischer -S Digitally signed by Michael T. Fischer -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2001136097, cn=Michael T. Fischer -S Date: 2021.07.02 14:33:10 -04'00'

Brian Hively -S Digitally signed by Brian Hively -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Brian Hively -S, 0.9.2342.19200300.100.1.1=2000536444 Date: 2021.07.02 17:24:55 -04'00'

Terry L. Frederick -S Digitally signed by Terry L. Frederick -S Date: 2021.07.09 13:55:23 -04'00'