A03_JA17052.signed_REDACTED.pdf

For Official Use Only

Control No:

Justification and Approval for Other Than Full and Open Competition

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S.

Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014.

2. Description of Action: Approval is requested for an extension, under authority of 52.217-8, to the current contract (W81XWH-11-D-0021 Task Order 129) using certified funds for a period of one (1) month for the procurement of technical expertise and support services for the conduct of regulatorily-required human subjects protection activities necessary to support the Human Subjects Protection Branch (HSPB) at the Walter Reed Army Institute of Research (WRAIR). The 30 day extension will allow sufficient time for HSPB to complete a separate competitive contract action to continue the support they are currently receiving. The estimated total cost of the extension is $58,000.00.

3. Description of Supplies/Services: The WRAIR HSPB is responsible for maintaining practices consistent with moral, ethical and legal standards, and assuring appropriate review and approval of human research activities in support of the WRAIR Institutional Review Board (IRB) and the larger based Human Research Protection Program (HRPP). The main objective of this requirement is to facilitate the timely, efficient, and regulatorily-sound review of research by providing the provisions necessary to meet WRAIR HSPB objectives. To meet the objectives the contractor will: provide human subjects protection regulatory support via the review of research protocols submitted to the WRAIR HSPB; ensure ongoing human subjects research/research is conducted in accordance with existing regulations, policies, and procedures, and provide training, as needed/requested; maintain a current database and records management system, as well as, corresponding records (hard copy and/or electronic); and, alleviate the administrative burden of the WRAIR IRB by maintaining files, preparing memoranda, meeting minutes, and additional documents on behalf of the IRB.

4. Authority Cited: Pursuant to FAR 6.302-2 and 10 USC 2304 (C)(2): The agency’s need for the supplies or services is of such an unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits bids or proposals, full and open competition need not be provided for.

5. Reason for Authority Cited: An additional extension of one (1) month is necessary to avoid a lapse in support for HSPB. The follow-on requirement (TOPR#: 17-0014) requires additional time to be awarded. The follow-on requirement is being competed Fair Opportunity against Research and Development Support Services (RDSS) Indefinite Delivery Indefinite Quantity (IDIQ).

The contract extension of W81XWH-11-D-0021 Task Order 129 will ensure that human subjects protection activities support continues without interruption for HSBP.

Clinical Research Management (CRM), the current contractor, has the unique knowledge, skills, and abilities to provide full support for HSPB starting on day one of the extension period of performance (PoP).

Technical expertise to support human subjects protection necessitates a thorough understanding of applicable federal regulations and guidances, Department of Defense (DoD) and Department of Army (DoA) policies, as well as, institutional requirements and procedures, to include, but not limited to: The Common Rule, 45 CFR 46 and all of its subparts (A-E); the Department of Defense (DoD) Common Rule 32 CFR 219; U.S. Food and Drug (FDA) regulations (21 CFR 50, 54, 56, 312, 612, 812, etc.); International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines; U.S. Department of Health and Human Services (DHHS) Office of Human Research Protections (OHRP) guidance documents; DoD Instruction 3216.02;

U.S. Army Medical Research and Materiel Command (USAMRMC) policies; WRAIR policies; and WRAIR HSPB procedures. Additionally, in support of activities occurring overseas (OCONUS), knowledge/understanding of applicable international policies/laws/regulations impacting human subjects protection is also required.

CRM personnel have the knowledge and expertise with HSPB procedures, protocols and have a thorough understanding of applicable federal regulations and guidances that govern HSPB. This unique level of understanding and familiarity is critical to the successful mission of HSPB.

Allowing another vendor to perform the extension would add unnecessary cost and burden to the government. Given the short term of the extension, 1 month, the learning curve would not allow sufficient time for any other vendor to contribute to the mission of HSPB and WRAIR. Typically a new vendor takes a minimum of a one to month transition period working alongside the current vendor to learn procedures, and develop the skills necessary to significantly contribute to the mission. Awarding this one month extension to another vendor places an unnecessary burden on the Government during the transition period, greatly increases performance risks, and will significantly delay projects that could impact critical public health research activities, (i.e. Zika studies).

6. Efforts to Obtain Competition: Only one known source can meet the Government’s urgent and compelling needs to provide support for the 30 day PoP. This extension of the current contract, W81XWH-11-D-0021 Task Order 129, continues CRM’s expert support. Competing this requirement will significantly delay projects that could impact public health and will have a negative impact on research at WRAIR.

7. Actions to Increase Competition: This extension will provide sufficient time to allow for completion of a competitive action for a five year contract to continue this support for HSPB.

8. Market Research: The COR has performed market research for the same product or services and verified that a new solicitation would not produce a more advantageous solution, other than that of awarding a 30 day extension to CRM. In addition, the current contract; W81XWH-11-D-0021 Task Order 129 contract price will be used as a comparison to estimated cost for the one month extension. Defense Contract Audit Agency reports are on file for this requirement.

9. Interested Sources: This is a one (1) month extension. Interested services have been identified for the five year follow- on contract currently out for Task Order Proposal Request.

10. Other Facts:

A. In addition to having knowledge and experience applying the applicable federal regulations and guidances stated in section 5, working knowledge of the additional references listed below is required:

• Army Regulation (AR) 70-25: Use of Volunteers as Subjects of Research, Headquarters, Department of the Army, dated 25 January 1990

• Department of the Army, U.S. Army Medical Research and Materiel Command (USAMRMC), Command Policy 2010-51, Ethical Use of Human Cadavers in USAMRMC Research, 8 November 2010

• Department of Defense (DoD) Instruction 3216.02, Protection of Human

Subjects and Adherence to Ethical Standards in DoD-Supported Research, dated November 2011

• WRAIR Policy Letter 12-05, Submission of Protocols Involving Human Subjects, Human Specimens, and/or Human Data for Scientific and Ethical Review

• WRAIR Policy 12-09, Determination that an Activity is Research Involving Human Subjects

• WRAIR Policy Letter 12-29, Assignment of Principal Investigators to Human

Subjects Research Conducted under the WRAIR Human Research Protection Program (HRPP)

• 32 Code of Federal Regulations (CFR) 219, National Defense, Protection of

Human Subjects

• National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Biomedical and Behavioral Research, dated 18 April 1979

No other vendor can provide the personnel with the required expertise needed to begin support of this requirement on day one of the thirty day PoP.

B. The anticipated award date for the larger follow-on contract (TOPR #: 17-0014) is mid-January 2017. It will be awarded as a task order under the RDSS IDIQ.

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.

SIGNED

11. 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.

Date

12. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

13. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.