Redacted_Justification_and_Approval_Document_Toxicology_Services_29_Sep_16.pdf

Control Number: 16-HRCO-282

For Official Use Only (See FAR 2.101 and 3.104-4)

Justification Review Document for Other than Full and Open Competition

Program/Equipment: Toxicology Support Services

Authority: FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Amount: The total estimated contract value is $3,425,447.00

Prepared by:

Typed Name: _ DSN:

Title: Contract Specialist _ Date: _5/31/2016

E-mail:

Contracting Officer:

Typed Name: DSN:

Date Reviewed: 18-Jun-2016 E-Mail:

Technical Representative:

Typed Name: DSN:

Title: Toxicologist Date Reviewed: 6/1/2016

Requirements Representative:

Typed Name: DSN: _

Title: Toxicologist Date Reviewed: 6/1/2016

(See FAR 2.101 and 3.104-4)

Control Number: 16-HRCO-282

Toxicology Support Services, Washington, D.C.

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Legal Counsel

Typed Name: DSN:

Signature: Date: 6-20-2016

Advocate for Competition

Typed Name: DSN:

Signature: Date: 6-30-2016

(See FAR 2.101 and 3.104-4)

Toxicology Support Services, Washington, D.C.

Justification and Approval for Other than Full and Open Competition

1. Contracting Activity: U.S. Army Health Contracting Activity (Provisional) (USAHCA (P)), Health Readiness Contracting Office (Provisional) (HRCO (P)), 2199 Storage Street, Building 4197, Suite 68, Joint Base San Antonio (JBSA) - Fort Sam Houston, Texas 78234-5074.

2. Description of Action: The HRCO (P) requests approval to negotiate a follow-on sole source contract for toxicology consultation services with The National Academy of Sciences (NAS). This is a non-personal service requirement. It is contemplated the resultant award will be a Cost Reimbursement Indefinite Delivery-Indefinite Quantity (IDIQ) contract. The type of funds to be used is Fiscal Year (FY) 16 Defense Health Program (DHP) Operation and Maintenance (OMA) Appropriation funds. Estimated share and ceiling arrangements and fee or profit are not applicable to this acquisition; reimbursement will be made for actual costs incurred without a fee.

3. Description of Supplies/Services: The NAS will provide expert opinion, advice, and consultation to the Department of Defense (DoD) on the matter of toxicology and related issues by reviewing available literature, reports, and data culminating in a report to the DoD. The required period of performance is 29 September 2016 to 28 September 2017 for the base period with two 1-year option periods. The total estimated contract value is $3,425,447.00. The contractor shall provide qualified personnel, services, materials, equipment, supplies and facilities necessary to maintain a standing committee on toxicology (COT) to investigate, examine, and report upon toxicology and related sciences, as required by the DoD, and return an autonomous reporting of the findings to the DoD. The contractor shall provide scientific support services in the form of a standing committee on toxicology (COT) and a toxicology information center (TIC). A detailed description of the required services is provided below:

a. Evaluation of toxicity information: This service provides for an analysis of the quality and value of toxicological information. The COT and its staff will assemble and organize data and provide bibliographies for wide-ranging toxicologically related subjects required by the sponsor. The Committee and its staff will assess the appropriateness and applicability of the data in the individual studies to the problems identified in specific requests from the sponsors. Since the time frame of response will vary from subject to subject, the COT will notify the sponsor within 30 days of receipt of the request of the time that it is expected to respond to a specific request.

b. Toxicological advice: The forte of the National Research Council is its capacity to assemble groups of leading scientific experts to deliberate issues. The COT has functioned well in this capacity for more than 60 years. The scope of its work has expanded considerably in recent years, and is reflected in the wide expertise of the current membership. The committee is composed of internationally known experts toxicology, medicine, occupational medicine, industrial hygiene, immunotoxicology, pharmacokinetics, biochemistry, pharmacology, inhalation toxicology, neurotoxicology, epidemiology, and risk assessment. When needed, the committee also has been able to call upon additional scientists with expertise in particular areas to provide added strengths

(See FAR 2.101 and 3.104-4)

Toxicology Support Services, Washington, D.C.

as appropriate. Toxicology analysis: The role of the committee will be the in-depth analyses of requests for toxicological advice, including specialized safety evaluations for military personnel.

The Committee will plan symposia and workshops to consider specific topics of interest to the DoD which will result in proceedings or reports. The products of the Committee’s deliberations will be technical reports which are formally peer reviewed prior to transmittal to the sponsors.

c. Toxicology information collection: Collect and maintain toxicity information from published and unpublished sources on a wide variety of substances to which humans are exposed, occupationally and environmentally.

d. Toxicology Coordination: Assist in coordination of toxicology programs within the sponsoring agencies.

e. Information Source: Serve as a medium of exchange; of toxicity information among the sponsors and between the sponsors and the scientific community.

4. Authority Cited: 10 United States Code 2304(c)(1) as implemented in Federal Acquisition Regulation 6.302-1(a)(2)(iii)(B), Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Reason for Authority Cited: The NAS, as scientific advisor to the Government, is the proposed source for this requirement due to their unique structure, capabilities and qualifications.

The NAS is the only sole source that can provide the widest spectrum of scientific knowledge and consensus concerning particular scientific areas of interest for which the Government requires intensive study and review. The NAS has the measure of expertise, independence, objectivity, and audience acceptance necessary to meet program requirements.

The U.S. Army has had the responsibility of contracting for the toxicology services of the National Academy of Sciences (NAS) for the joint services since 1982. The NAS was chartered by Congress to conduct studies in the field of science when called upon by the Government. The Federal Government-NAS relationship is defined in the 1863 Congressional Act of Incorporation which required the Academy to investigate, examine, experiment, and report upon any subject of sciences. The primary resources for addressing the relevant needs of the DoD sponsors (Dept. of the Army, Dept. of the Air Force and Dept. of the Navy) are the NAS Committee on Toxicology (COT), its professional staff, and the staff and collection of the Toxicology Information Center (TIC). The combination of these resources, with broad policy guidance of the Board on Environmental Studies and Toxicology, provides the most efficient and economic utilization of scientific expertise and technical support facilities. The purpose of this contract is to obtain surveys, analysis and studies from leading experts in the field of Toxicology and related fields, as ordered by the Departments of the Army, Navy and Air Force. The credibility of NAS reports is maximized by the recognized impartiality of the institution, which manufactures no product, possesses no funds to disperse, and has no power of decision over the scientific establishment.

Professionals in government, academia, and industry read the NAS report publications to keep abreast of progress or to address particular issues in depth. The Academy’s reports stand as

(See FAR 2.101 and 3.104-4)

Toxicology Support Services, Washington, D.C.

authoritative resources for legislative decisions, regulatory positions and for allocation of scientific resources in the Government.

6. Efforts to Obtain Competition: In accordance with DFARS PGI 206.303-2(b)(i) sources sought notification to identify potential sources capable of fulfilling this requirement was solicited via the Government Point of Entry at https://www.fbo.gov/ on 23 March 2016. A total of three vendors responded to the notice and stated that they had the capability of providing the required services. A technical review of the responses received was conduct by the requiring activity to determine if the interested sources could provide the required services. The technical expert determined that while the interested vendors are capable of providing toxicology support services they do not possess the magnitude of expertise required to support the DoD Committee on Toxicology and supporting services based on the following.

The Committee on Toxicology (COT) has provided advice to the Department of Defense and other Agencies since 1947. The COT is composed of invited scientists from a wide area of disciplines that are tailored to specific tasks on a need-by-need basis. These ad hoc committees vary widely between tasks and are disbanded at the end of each task. Scientists invited to serve on NAS committees are carefully vetted and serve on a pro bono basis, with travel, accommodation, and meals provided. This reduces any potential conflict of interests. While other vendors may offer a range of multidisciplinary approaches from in-house salaried staff scientists and experts, none of them have the pro bono approach and variety of rotating personnel provided by the NAS. Scientists invited to participate in an NAS committee consider it an honor, professional privilege, and national duty and the pro bono approach gives an air of authenticity not always available from the private sector. The time period required to establish a committee such as the NAS COT, as well as ad hoc sub-committees devoted to specific tasks by any vendor could result in a delay in the ability to provide required services immediately upon contract award as well as the potential for increased cost associated with the establishment committees.

The imprimatur that a NAS report provides cannot be replicated by private vendors, even though these potential vendors may have high levels of in-house experts at their disposal. NAS published reports carry a weight of authority that acts as a “supreme court” of opinion on important issues to the DoD and is best acceptable to the widest possible range of stakeholders. Awarding this authority to a private vendor would invite a range of difficulties and there would be a loss of credibility for some critical reports. In the past, critical DoD reports carried out by private vendors have occasionally needed to be vetted by the COT. The NAS has a standing of carefully vetting all participants ensuring there are no perceived conflicts of interest that could possibly affect the final product.

The NAS has officially been deemed “advisor to the government” and while there is no regulation that prevents contracts to private vendors for some tasks, the continuity of expert opinion provided since World War II by the COT has been beneficial to the Government, the interested vendors lack experience in providing the level of expertise provided by the COT to the DoD. Assembly and recreation of an equivalent structure to that which now exists for the COT at the NAS would be a

(See FAR 2.101 and 3.104-4)

Toxicology Support Services, Washington, D.C.

cost prohibitive venture and would also result in a loss of continuity to the DoD that would be difficult to justify.

NAS committees have well established open public comments periods in their deliberations where members of the public can address the committee. Final reports are made available free to the public via the National Academy Press website which is searchable and maintained by the NAS.

Hard copies of reports published by the NAS can be purchased years after a study has been completed. While such procedures and accessibility could be provided by private vendors, the establishment of an equivalent structure to the NAS COT would be a reinvention of a process that would result in increased costs to the contract.

a. Effective competition. Effective competition is not anticipated for this acquisition.

b. Subcontracting competition. The NAS committees are comprised of the nation’s top scientists and other experts who volunteer their time to study specific concerns and the only portion of services available for subcontracting possibilities is administrative staff for which the NAS customarily maintains sufficient in-house capability to provide performance of their works.

Therefore, there are no subcontracting opportunities possible and there are no efforts which can be taken by the Government to ensure that the prime contractor obtains as much competition as possible in its subcontracting.

7. Actions to Increase Competition: There does not appear to be any actions that can be taken to increase competition for a subsequent acquisition of these services. The service required is unique to the Government and the capability of providing that service is unique to the NAS since they are currently the only identified source that can conduct scientific studies in the field of toxicology and related sciences and return an autonomous reporting of the results to the DoD. Market research efforts for subsequent procurements will dictate whether additional sources become available.

8. Market Research: Market research was conducted within the past 12 months, efforts included the SS Notice previously discussed and a web-based search for toxicological services. The extent of market research conducted reaffirmed that the NAS is the only source that can provide the measure of expertise, independence, objectivity, and audience acceptance necessary to meet the requirement. While market research reveals that there are other institutions capable of conducting studies and providing advice on science, technology, and public policy, the NAS is a non-profit society of distinguished scholars, has a large pool of distinguished scientists who are experts in relevant sciences and are appointed for 3-year terms by the NRC. COT's list of distinguished past and present members include national and international leaders in such fields as toxicology, epidemiology, occupational health, pharmacology, pathology, biochemistry, chemistry, industrial hygiene, biostatistics, and risk assessment. Members are chosen from universities and other institutions for their professional qualifications, judgment, and integrity. They bring to the committee's deliberations the expertise that enables authoritative and thorough examination of the problems presented. The members of COT have included current and past presidents of the Society of Toxicology, the Teratology Society, and the Society for Risk Analysis. COT's current roster includes members of NAS, advisers to the International Agency for Research on Cancer, and members of the science advisory boards of the National Institutes of Health and EPA.

(See FAR 2.101 and 3.104-4)

Toxicology Support Services, Washington, D.C.

When an agency requests a study, the NAS COT develops a project plan and seeks approval from its parent organizations within the Academy complex: the Board on Environmental Studies and Toxicology, the Commission on Life Sciences, and the NRC Governing Board. Once approval is obtained and financial support by sponsors is arranged, the COT and the National Research Council (NRC) identify renowned scientists with appropriate expertise to undertake the project.

The scientists review the literature and other pertinent materials and prepare a consensus report.

Before the report is released, it is edited and submitted to rigorous external peer review according to procedures of the NRC Report Review Committee. Because COT reports carry the weight and the authority of the NRC, report review is an integral part of producing a COT report. Critical and careful review helps to ensure that the highest scientific and expository standards are met. The NAS charter commits the Academy to provide scientific advice to the government “whenever called upon” by any government department. The Academy receives no compensation from the government for its services.

Other non-profit organizations, educational institutions, and corporate entities that were identified and expressed interest are either privately funded, are not willing to offer their services at no compensation, do not have a large pool of distinguished scientists, comparative to the ones selected for the COT, to draw from, and/or are not recognized as an authoritative expert in the field of toxicology.

9. Interested Sources: A total of three responses from interested vendors were received in response to the sources sought notification posted via the GPE. The notices required by FAR5.201 will be published and any bids, proposals, quotations, received will be considered by the contracting officer

10. Other Facts: The U.S. Army has had the responsibility of contracting for toxicology services for the joint services since 1982.

a. Procurement history.

(1) Contract numbers and dates of the last several contracts for these same requirements

Contract Number Term Authority for Other than Full and Open

Competition

DAMD17-83-C-3028 01 Nov 82 - 31 Jan 86 10 U.S.C. 2304 (a)(11) as implemented by DAR 3-211.1 DAMD17-86-C-6151 24 Feb 86 - 20 Jan 89 10 U.S.C. 2304 (c)(l) as implemented by FAR 6.302-1 DAMD17-89-C-9086 21 Jan 89 - 31 Jan 99 10 U.S.C. 2304 (c)(l) as implemented by FAR 6.302-1 DAMD17-99-C-9049 28 May 99 - 27 May 04 10 U.S.C. 2304 (c)(l) as implemented by FAR 6.302-1 W81K04-05-C-7006 08 Jun 05 - 07 Dec 05 10 U.S.C. 2304 (c)(l) as implemented by FAR 6.302-1 W81K04-06-D-0023 29 Sep 06 - 28 Sep 11 10 U.S.C. 2304 (c)(l) as implemented by FAR 6.302-1 W81K04-11-D-0017 29 Sep 11 - 28 Sep 16 10 U.S.C. 2304 (c)(l) as implemented by FAR 6.302-1

(2) The competitive status of these previous actions was sole source. Market research conducted from 2 February 2016 through 31 March 2016, did not identify any additional sources which are

(See FAR 2.101 and 3.104-4)

Toxicology Support Services, Washington, D.C.

capable of providing the measure of expertise, independence, objectivity, and audience acceptance necessary to meet the requirement

(3) The authority previously cited for the less than full and open competition is referenced in the above chart.

(4) The previous justification document, Center for Health Care Contracting J&A Control No: 11- 013, stated the following: “There does not appear to be any actions that can be taken to increase competition for a subsequent acquisition of these services. The service required is unique to the Government and the capability of providing that service is unique to the NAS since they are currently the only identified source that can conduct scientific studies in the field of toxicology and related sciences and return an autonomous reporting of the results to the DoD. Market research efforts for subsequent procurements will dictate whether additional sources become available”.

Market research conducted from 2 February 2016 through 31 March 2016, did not identify any additional sources which are capable of providing the measure of expertise, independence, objectivity, and audience acceptance necessary to meet the requirement.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. N/A

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. N/A

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. The previous circumstances that justified a sole source procurement was the Government’s determination that the award of a contract to a new source for such highly specialized services would result in substantial duplication of cost to the Government that is not expected to be recovered through competition

b. Other facts. Provide any other facts necessary to justify limiting competition that were not previously stated. N/A

(See FAR 2.101 and 3.104-4)

Toxicology Support Services, Washington, D.C.

1. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Signature: Date: 6-7-2016

Typed Name: Title: Toxicologist

2. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Signature: Date: 6-7-2016

Typed Name: Title: Toxicologist

3. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable based on price analysis and/or cost analysis in accordance with FAR 15.404-1, and comparison with the independent Government estimate. Per DFARS 215.403-1(c)(4)(D), DoD has waived cost or pricing data requirements for nonprofit organizations (including educational institutions) on cost-reimbursement, no fee contracts, therefore certified cost or pricing data will not be required.

Signature: Date: 18-Jun-2016

Typed Name: Title: Contracting Officer

4. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature: cn= Date: 18-Jun-2016

Typed Name: Title: Contracting Officer

Toxicology Support Services, Washington D.C.

Approval

Based on the foregoing justification, I hereby approve the procurement of Toxicology Support Services for the period of 29 September 2016 to 28 September 2017, plus two 12 month option periods not to exceed $3,425,447.00 on an other than full and open competition basis pursuant to the authority of 10 United States Code 2304(c)(1) as implemented in Federal Acquisition Regulation 6.302-1(a)(2)(iii)(B), Only one responsible source and no other supplies or services will satisfy agency requirements, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature: Date:

Typed Name: Title: USAHCA (P) Special Advocate for Competition

For Official Use Only (See FAR 2.101 and 3.104-4)

30 June 2016