1. Sole source justification (posting ver).docx

National Institutes of Health Office of Purchasing and Contracts

Date: 31 March 2025

Subject: JUSTIFICATION AND APPROVAL (J&A) – JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. AGENCY IDENTIFICATION AND CONTRACTING ACTIVITY:

AGENCY:

Point of Contact: Nathaniel Johnson, Section Chief, Storage & Distribution, MMESD Point of Contact Phone #:

Point of Contact Email:

Requiring Activity: National Institutes of Health (NIH), Clinical Center (CC), Materials Management and Environmental Services Department (MMESD) Address: NIH Clinical Center 10 Center Drive Building 10, Room B2N248A Bethesda, MD 20892

CONTRACTING ACTIVITY:

National Institutes of Health (NIH) Clinical Center (CC) Office of Purchasing and Contracts (OPC) Two Democracy Plaza 6707 Democracy Boulevard, Suite 106 Bethesda, Maryland 20892

2. NATURE AND/OR DESCRIPTION OF THE ACQUISITION BEING APPROVED:

This action will be awarded as a new sole source contract in accordance with Federal Acquisition Regulation (FAR) 6.302-1. The Government intends to make a one-time purchase of Good Manufacturing Practices (GMP) Cleaning Supplies with

VWR International 1310 Goshen Parkway Westchester, PA 19380

3. DESCRIPTION OF THE SUPPLIES AND SERVICES REQUIRED, INCLUDING THE DELIVERY SCHEDULE AND/OR THE PERIOD OF PERFORMANCE AND DOLLAR VALUE OF THE ACQUISITON:

The MMESD, Storage & Distribution Section has a requirement for contamination control cleaning supplies for NIH biologics manufacturing sites and aseptic processing areas at the NIH CC (Bldg. 10) on the Bethesda, MD campus. It is vital that the Contractor provides Certificates for Analysis (COA), Certificates of Conformance and Packing Inserts in each packaged case of supplies. The requirement is to obtain cleaning supplies for the NIH, Clinical Center cGMP Clean Rooms for delivery to Building 10, Room B2C-123 Bethesda, Maryland. It is critical to adequately clean these rooms with the needed Government approved cleaning supplies to be able to pass the Joint Commission and FDA Certifications for cGMP pharmaceutical development practices.

ORSC and the Pharmacy cGMP Cleaning Supplies.

The estimated value of this procurement is $249,786.46 which includes freight charge at no charge. A price analysis was conducted in accordance with FAR 13.106-3 using past contractual pricing and informal vendor estimates. After extensive comparative analyses using the aforementioned methods, the price of $249,786.46 was determined to have been fair and reasonable for the Government.

4. IDENTIFICATION OF STATUTORY AUTHORITY PERMITTING OTHER THAN FULL AND OPEN COMPETITION:

|X| FAR 6.302-1 – Only one responsible source and no other supplies or services will satisfy agency requirements [41 USC 253(c) (1)]: The supplies or services required by the Agency are available from only on responsible source and no other supplies or services will satisfy agency requirements.

|_| FAR 6.302-1(c) – Only one responsible source and no other supplies or services will satisfy agency requirements [41 USC 253(c) (1)]: Brand Name Justification. The use of such descriptions in the acquisition is essential to the Government’s requirement, thereby precluding consideration of a product manufactured by another company.

|_| FAR 6.302-2 – Unusual and compelling Urgency [41 USC 253(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. (NOTE: These justifications may be made and approved after contract award when preparation and approval prior to award would unreasonably delay the acquisition. Lack of advanced planning is not justification for the use of this authority.)

|_| FAR 6.302-3 – Industrial Mobilization; engineering, development, or research capability; or expert services [41 USC 253(c) (3)]: It is necessary to award the contract to a particular source or sources in order (i) to maintain a facility, producer, manufacturer, or other supplier available for furnishing supplies or services in case of a national emergency or to achieve industrial mobilization, or (ii) to establish or maintain an essential engineering, research, or development capability to be provided by an educational or other nonprofit institution or a federally funded research and development center or (iii) to acquire the services of an expert neutral person for any current or anticipated litigation or dispute.

|_| FAR 6.302-4 – International agreement [41 USC 253(c) (4)]: Full and open competition need not be provided for when precluded by the terms of an international agreement or a treaty between the United States and a foreign government or international organization, or the written directions of a foreign government reimbursing the agency for the cost of the acquisition of the supplies or services for such government.

|_| FAR 6.302-5 – Authorized or required by statute [41 USC 253(c) (5)]: A statute expressly authorizes or requires that the acquisition be made through another agency or from a specified source, or the agency's need is for a brand-name commercial item for authorized resale.

|_| FAR 6.302-6 – National security [41 USC 253(c) (6)]: The disclosure of the agency's needs would compromise the national security unless the agency is permitted to limit the number of sources from which it solicits bids or proposals.

|_| FAR 6.302-7 – Public Interest [41 USC 253(c) (7)]: The agency head determines that it is not in the public interest to use full and open competition in the particular acquisition concerned.

5. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED:

The NIH Clinical Center MMESD, Storage & Distribution Section is the sponsoring institution at the National Institutes of Health responsible for providing medical/surgical and cleaning supplies in support of the GMP. These GMP Cleaning Supplies plays a pivotal role in direct support of GMP and patient care.

6. A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE SOLICITED FROM AS MANY POTENTIAL SOURCES AS PRACTIABLE:

In accordance with FAR 5 – Publicizing Contract Actions, a Notice of Intent to Sole Source shall be issued for a period of ten (10) days via beta.sam.gov. There are no other companies that can provide this product, due to the Certificate of Acceptance (COA), Certificate of Compliance (COC), Packing Slip and company website access, so the customer can access the above-mentioned COA, COC and Packing Slip.

7. DEMONSTRATION THAT THE ANTICIPATED COST WILL BE FAIR AND REASONABLE:

The anticipated cost associated with this procurement is $39,375.29. This pricing is considered to be fair and reasonable to the Government in accordance with FAR 13.106-3 (i) (ii) (vi) which takes into account market research conducted by the customer and Contract Specialist, comparisons of the proposed price with prices found reasonable on previous purchases, and the total amount given on the Independent Government Cost Estimate (IGCE).

8. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND THE RESULTS OR STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED:

In accordance with FAR Part 10.002 (2) and (b) (1), There was market research conducted and there were no companies found that can provide the COA, COC, Packing Slip and website Access. The VWR International was the only company that can provide the requested COA, COC, Packing Slip and website access.

After an extensive query and survey of the market was completed, only one (1) capable source was discovered who can suffice the Government’s need. The company is as follows:

COMPANY NAME: VWR International COMPANY ADDRESS: 1310 Goshen Parkway Westchester, PA 19380

COMPANY PHONE: 1-800-932-5000

NAICS:

SOCIO-ECONOMIC CATEGORY: Large Business

9. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL AND OPEN COMPETITION:

There are currently no other supporting facts for the use of Other Than Full and Open Competition to be utilized at this time. All current and relevant information involved with the use of Other Than Full and Open Competition has been provided within this justification document.

10. LISTING OF SOURCES, IF ANY, THAT EXPRESSED, IN WRITING, AN INTEREST IN THE ACQUISITION:

A Notice of Intent to Sole Source to VWR International will be posted via beta.sam.gov for a period of three (3) days. Results of this notice will be included within the acquisition file.

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:

For future acquisitions, events such as Industry Days may be conducted to grant prospective contractors the opportunity to complete an accompanied tour of the NIH Clinical Center to become more familiar with this requirement. These in-person visits will be more beneficial for the removal of competition barriers in contrast with Requests for Information (RFI) or Sources Sought Notices. Business Events that promote the articulation of NIH requirements would allow for prospective contractors to provide Capability Statements or network with incumbent contractors who possess the experience needed to suffice specialized requirements of this nature.

12. ADMINISTRATIVE OFFICER/PROGRAM OFFICIAL CERTIFICATION:

Pursuant to FAR 1.707 Signature Authority, this Justification has been thoroughly reviewed and recommends approval. I certify that the above facts and representations under my cognizance that are included in this Justification are accurate and complete to the best of my knowledge and belief.

Nathaniel Johnson______________________________________ Nathaniel Johnson, Section Chief, Storage & Distribution, MMESD

FAC-COR II

13. CONTRACTING OFFICER’S CERTIFICATION

Pursuant to FAR 1.707 Signature Authority, this Justification has been thoroughly reviewed and recommends approval. I certify that the above facts and representations under my cognizance that are included in this Justification are accurate and complete to the best of my knowledge and belief.

Christopher Lauver Section Chief, National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) image1.png image2.jpeg