a. Leading NIH’s Biosafety Modernization Initiative, an NIH Director priority involving a comprehensive effort to modernize and strengthen biosafety policies, practices, and oversight to keep pace with evolving risks posed by rapidly advancing science and technology. This includes development of a new, comprehensive biosafety policy framework to be issued by the end of the year. Adequate contractor support is essential to meeting this commitment.

b. Administration of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), the primary Federal framework governing biosafety oversight of such research. Activities include:

o Registering and maintaining Institutional Biosafety Committees (IBCs) in the NIH OSP Registration Management System, including review and approval of committee membership (more than 4,000 registered IBCs), which serve as the foundation of institutional biosafety oversight in the United States o Assessing and making determinations regarding appropriate biosafety levels and containment requirements to ensure protection of public health o Responding to approximately 1,000 biosafety inquiries annually o Reviewing and responding to approximately 250 biosafety incident reports annually

c. Administration of the National Science Advisory Board for Biosecurity (NSABB), a

Congressionally mandated Federal advisory committee, including operational, logistical, and policy support on behalf of HHS. The purpose of the National Science Advisory Board for Biosecurity (NSABB) is to provide technical advice, guidance, or recommendations, to relevant Federal departments and agencies related to biosafety and biosecurity oversight of biomedical research, including — (1) oversight of federally-conducted or federally-supported dual use biomedical research, such as the review of policies or frameworks used to assess and appropriately manage safety and security risks associated with such research, taking into consideration national security concerns, the potential benefits of such research, considerations related to the research community, transparency, and public availability of information, and international research collaboration; and (2) pursuant to section 205 of the PAHPA, when requested by the Secretary of Health and Human Services (Secretary) (a) a core curriculum and training requirements for workers in maximum containment biological laboratories; and (b) periodic evaluations of maximum containment biological laboratory capacity nationwide and assessments of the future need for increased laboratory capacity.

d. Support to interagency coordination efforts, including:

o The National Bioeconomy Board o The HHS Biosafety and Biosecurity Coordinating Council, which provides a formal mechanism to coordinate biosafety and biosecurity issues across HHS and with the Executive Office of the President

e. Participation in specialized Federal advisory and oversight groups, including:

o CDC’s Intragovernmental Select Agents and Toxins Technical Advisory

Committee (ISATTAC) (2 supported members) o NIAID’s Interagency Select Agent Review Group (ISARG) (1 supported member)

In addition, OSP has been assigned expanded responsibilities to lead Federal efforts to strengthen oversight of life sciences research with biosafety and biosecurity implications, including work at the intersection of biosecurity and bioeconomy.

These activities are ongoing, high-volume, and essential to maintaining Federal oversight of biosafety and biosecurity. Any interruption in contractor support would result in immediate degradation of these functions and increased risk to public health and national security.

4. Authority Cited and Rationale: Authority of the FSS Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 251, et seq.); Title 40 U.S.C. 501, Services for Executive Agencies, as implemented at FAR 8.401 and GSAM/R 538.7104-3(b)(1).

a. GSAM/R 538.7104-3(b)(1)(i)- The need is of such unusual urgency that following the procedures would result in unacceptable delays in fulfilling that need.

The Government has an immediate and compelling need to continue these services without interruption through a short-term three-month bridge. The activities described above are continuous, time-sensitive, and integral to NIH’s ability to carry out its biosafety and biosecurity responsibilities.

A lapse in contractor support would result in:

• Disruption in oversight of more than 4,000 Institutional Biosafety Committees

• Delays in biosafety incident response and inquiry resolution

• Interruption of Administration-directed biosecurity policy development and implementation

• Degradation of interagency coordination and advisory committee operations

• Lack of support for the National Science Advisory Board for Biosecurity (NSABB). The NSABB is the only Federal advisory committee chartered to advise the Federal Government on the management and oversight of dual use research; a constantly evolving challenge with significant implications for national biodefense, biosafety and biosecurity, and maintenance of a strong U.S. bioeconomy. Such impacts would seriously impair the Government’s ability to protect public health and ensure safe conduct of high-risk biological research.

Performance requires contractor personnel to complete applicable NIH Division of Personnel Security and Access Control (DPSAC) and Department of Homeland Security processes and obtain the necessary credentials, system access, and facility access. Based on anticipated processing timelines, onboarding new contractor personnel and obtaining the required approvals is expected to take approximately six to eight weeks.

HHS made a competitive award of a task order for these services with a one-year base period and four one-year option periods. However, a post-award protest was filed before the Government Accountability Office challenging the competitively awarded task order. This sole source task order will have a base of three months, to cover the minimum period reasonably necessary to ensure that there is continuation of services while the protest is resolved. The task order will also include FAR 52.217-8 Option to Extend Services to ensure that there is continuation of coverage if needed following the outcome of the protest.

b. GSAM/R 538.7104-3(b)(1)(ii)- Only one source is capable of providing the products, services, or solution required at the level of quality required because the products, services, or solutions are unique or highly specialized.

Additionally, NCP is the only source capable of successfully performing the requirement during the pendency of the protest. Prior to the stop-work order taking effect, most of the incumbent workforce had already transitioned to the NCP. As a result, it is the only source that presently possesses the experienced personnel, institutional knowledge, and required clearances necessary to resume performance without an additional transition and unacceptable disruption to the Government's requirements.

No other source could assume performance during the protest period without first recruiting or transitioning personnel, acquiring the necessary institutional knowledge, and getting staff clearances. Given the limited and uncertain duration of the protest, an interim transition would create unacceptable performance and continuity risks and could itself require reversal once the protest is resolved.

Continued performance by NCP is also necessary to preserve the experienced workforce needed for any subsequent transition. If the Government does not prevail in the protest and performance must transition to another awardee, these personnel will be essential to transferring institutional knowledge and ensuring continuity of operations. Continued suspension increases the risk that these personnel will leave or be reassigned, potentially depriving both the Government and any successor contractor of the expertise necessary for an orderly transition.

Accordingly, NCP is the only source presently capable of meeting the Government's immediate requirements while simultaneously preserving the workforce and institutional knowledge necessary to support transition to the ultimate awardee following resolution of the protest.

5. Market Research:

Market research conducted in the last three months indicates that while other small business vendors may be capable of performing similar services, none can provide uninterrupted support within the timeframe required. Market research for future competitions will be done to ensure that NIH/HHS is able to ensure maximum competition.

6. Procurement history:

a. Contractor: Salient CRGT, Inc. (Subsidiary of GovCIO) Contract or Order Number: 75N98021A00084 Award Date and Period of Performance: POP 7/26/21 – 7/25/2026, ultimate completion date of 09/15/2026 Value (including all options):

Competitive Status: Full and Open Competition after Exclusion of Sources (Small Business Set-aside – Total).

Authority formerly relied upon if Not Competed: Modifications were issued which increased the total value and period of performance after the competitive award, through authority set forth in GSAR/M 538.7104-3 (a)