AoI-0001 DOMESTIC INDUSTRIAL BASE EXPANSION OF ACRYLONITRILE BUTADIENE RUBBER (NBR) for NITRILE MEDICAL GLOVES (Revision 4).pdf

AoI-0001 DOMESTIC INDUSTRIAL BASE EXPANSION OF ACRYLONITRILE BUTADIENE RUBBER (NBR) for NITRILE MEDICAL GLOVES

1. Glove Industrial Base Expansion Area of Interest (AoI) Background

The recent COVID-19 Public Health Emergency has illuminated the importance of increasing the United States’ domestic capacity to manufacture medical gloves, Acrylonitrile Butadiene Rubber (NBR) and key chemicals to produce NBR for glove manufacturing. To date, the United States Government (USG) has invested in the domestic production of approximately 1.5B nitrile gloves per month that is capable of meeting 41% of the nation’s demand for acute and non-acute care nitrile gloves. The USG believes it will need to expand NBR production to 270K wet metric tons annually to “feed” the U.S. domestic nitrile glove production. To date, the USG has invested in the domestic production of 90K wet metric tons of NBR. The USG has a minimum requirement to produce an additional 180k wet metric tons per year to sustain the domestic glove industry. The intent of this AoI is to understand the industry’s ability to increase the NBR for nitrile medical glove manufacturing capacity. The country’s ability to increase and sustain domestic manufacturing capacity to a minimum of 1.5 billion medical gloves per month is critical to not only respond to the current pandemic or future pandemics but also to ensure the security of glove manufacturing within the US. Securing the raw material is an essential piece to this success.

The Office of the Secretary of Defense for Acquisition and Sustainment (OSD(A&S)) Joint Rapid Acquisition Cell (JRAC), Defense Assisted Acquisition (DA2), Personal Protective Equipment (PPE) Team and Department of the Air Force Acquisition Team (DAF ACT) need to understand industry’s ability to increase domestic manufacturing of NBR used in manufacturing sterile, powder-free, patient examination gloves.

2. AoI Expansion Request

This AoI solicits solution briefs to support the Department of Health and Human Services Assistant Secretary for Preparedness and Response (DHHS/ASPR) priorities for meeting public health/pandemic needs to expand domestic production capacity of glove manufacturing NBR within the next 6-24 months. Offerors can respond based on their resident expertise and ability to expand domestic manufacturing. The DA2 would like to understand industries’ ability to expand their domestic capacity to produce NBR for the production and manufacturing of acute and non-acute care nitrile medical gloves.

This effort is to carry out various provisions of the Defense Production Act. As such, and for purposes of the Defense Production Act, “domestic sources” generally means:

A business concern –

a) that performs in the United States or Canada substantially all of the research and development, engineering, manufacturing, and production activities required of such business concern under a contract with the United States relating to a critical component or a critical technology item; and

b) that procures from business concerns described in subparagraph (A) substantially all of any components and assemblies required under a contract with the United States relating to a critical component or critical technology item.

All resultant contracts of this AoI will be subject to the Priority Access language identified in the Commercial Solutions Opening and below.

By entering into this [CONTRACT/AWARD/AGREEMENT)], the [CONTRACTOR/RECIPIENT/AWARDEE] agrees to be legally bound to provide the U.S.

Government with Priority Access for a 10-year period, starting from the completion of the capacity/expansion project that is the subject of this [CONTRACT/AWARD/AGREEMENT], notwithstanding the conclusion of any other commitments at the end of this [CONTRACT/AGREEMENT/AWARD]’s period of performance. “Priority Access” is defined, for the purposes of this [CONTRACT/AGREEMENT/AWARD], as: “upon a determination by the HHS Secretary that [FILL IN DESCRIPTION] is needed to prepare for or respond to a disease, health condition or other threat to the public health that causes a public health emergency or a credible risk of such an emergency, the U. S. Government has priority access to [CAPACITIES THAT THE U.S. GOVERNMENT WILL RECEIVE PRIORITY ACCESS TO] over any other non-rated ((Defense Priorities and Allocations System (DPAS)/ Health Resources Priority and Allocations System (HRPAS)) contract or order, and, for the purpose of assuring such priority, shall be required to accept and perform such DPAS/HRPAS rated contracts or orders in preference to any other non-rated (DPAS/HRPAS) rated contracts/orders during this 10 year period.” If the [CONTRACTOR/RECIPIENT/AWARDEE] novates or otherwise transfers responsibility for performance under this [CONTRACT/AWARD/AGREEMENT] and the commitments herein to any other entity, the Priority Access requirement shall follow the transfer, and this language concerning Priority Access shall be included in any transfer agreement and affirmed by the transferee. The parties agree to negotiate in good faith for continued U.S. Government Priority Access, as defined herein, to extend beyond this 10-year period.

3. Specific Information for NBR DOMESTIC PRODUCTION OF RAW GLOVE MATERIAL

NBR, also known as acrylonitrile butadiene rubber, Buna-N, and nitrile butadiene rubber, is a synthetic rubber derived from acrylonitrile and butadiene. NBR is a necessary ingredient in manufacturing medical grade gloves. This section is focused on growing industrial capability to produce NBR for nitrile medical gloves within the US.

1) What would be required for your company to increase domestic production of NBR?

2) Provide a list of your company’s current NBR production capacity in wet Metric Tons (MT) of glove material and the equivalent of how many medical gloves annually it could produce (Table 1 - sample) if applicable or where production would occur.

Table 1 Sample list of current NBR material capacity

LOCATION

QUANTITY (Wet MT/YEAR) GLOVE EQUIVALENT/YEAR

*Indicate the formula used to convert.

3) Does your company have all the current Good Manufacturing Practices, Environmental

Protection Agency and/or Food and Drug Administration regulatory approvals for the manufacture of the NBR? If not, what is the company’s strategy to have this in place?

4) Provide a list of proposed NBR manufacturing information (full production date, wet metric tons/year) to be increased domestically. An example format is shown in Table 2.

The timeline to initial material production (ramp up to full production) should take into consideration completion of applicable permits, equipment purchases and installation, facility set up (utilities, water treatment, testing etc.).

Table 2 Sample List of NBR Production Data Requested

FULL

PRODUCTION

DATE

QUANTITY

(Wet MT/YEAR)

*MEDICAL GLOVE

EQUIVALENT/YEAR

LOCATION

TOTAL COST

*Indicate the formula used to convert.

5) Explain what method you used to justify and prioritize your chosen location(s).

a) Does the US NBR facility include existing property or new real property?

6) Address required capital investments and additional projected costs (i.e. facilities, labor etc.).

7) Estimate the change in market cost because of the increased material capacity generated by this investment

8) Identify barriers to domestic production and their impacts (i.e. regulatory, legal, legislative, policy, decreased business due to higher production costs, etc.)

9) Provide an estimate of sustainment plans/expectations for this domestic capability post USG investment.

10) Describe plans to remain commercially viable without continual government demand or investment to justify your decision, INCLUDING YOUR OVERALL SUPPLY CHAIN STRATEGY

AND STEPS YOU WOULD TAKE TO ENSURE SUPPLY CHAIN RESILIENCE AGAINST

DISRUPTION.”

11) Identify any foreign suppliers within your supply chain and identify your plan to source from domestic sources (and the timeline) as appropriate and the method used to justify your decision.

12) Describe partnerships, licensing arrangements or other commercial agreements that might help to reach scale more quickly and what terms and conditions would be required.

13) Is there an opportunity for cost sharing? Provide either a dollar amount or percentage of proposed cost.

14) Please provide multiple options with low, medium and high levels of investment. Is it possible to compress your production schedule? If so, please provide details on the cost and benefit of each level of investment.

15) This contract is to increase the US industrial base only. There is no implied or explicit intent to follow this contract with further contractual arrangements with the government to purchase material. Your proposal must prepare your company to be self-sufficient and not dependent on any further government investment. If you place any contingencies in your proposal for future product purchases your proposal will be disqualified.

16) This solicitation is not intended for material distributors or resellers, but is focused solely on material manufacturing capacity.

17) If you are purchasing equipment/machines from a foreign source, please provide information of the source and timelines of purchase to machine set up.

a) If foreign workers will be assisting with the equipment set up, are work visas being considered and will there be impacts to the timeline?

18) Please ensure that you provide as much information as you can, that it is thorough, and accurate, as this is the only information being evaluated moving forward in the CSO

(NBR) for NITRILE MEDICAL GLOVES

Process. You will be competing with other offerors for the NBR material industrial base expansion.

19) Do you have a business continuity plan and have you identified critical equipment and power sources to maintain that equipment during an outage, cyber incident, etc.?

20) What regulatory and quality standards would be needed to implement production, e.g.

ISO 9001?

21) What safety, health & environmental (SHE) certifications would be needed (e.g., Responsible Care certification, ISO 14001, OHSAS 18001, etc.)? What timelines would be needed for each of these certifications if not already obtained?

22) Provide any additional relevant information for consideration by the review team.

4. SPIRAL 1 through 3– Submission Requirements ALL overarching CSO submission requirements are applicable to any AOI submission.

1) All guidance governing the content and evaluation criteria for required submission can be found the below at the following JRAC DA2 CSO link:

https://sam.gov/opp/7504925c5ade4052a4c46f2513b5d9b6/view/.

2) Solutions briefs for this Area of Interest shall be submitted at the email below:

NBR.cso.dafact@afwerx.af.mil

3) Once submission is received, offerors will receive a Response Submission Number via email.

Please ensure that your solution brief has your firm’s point of contact information to include Name, Title, Phone number and Email.

5. AoI Open Period

1) Questions pertinent to this AoI should be sent to NBR.cso.dafact@afwerx.af.mil by 4:00 PM CST, 12 November 2021.

2) Solution Briefs may be submitted immediately upon reviewing this AOI. Solutions Briefs will be accepted until 7 December 2021, 4:00 PM CST.

a) Amendments to previously submitted solutions will be accepted. Solution amendments shall be clearly marked and the original tracking number shall be included in the subject of the email.

b) Amended proposals shall replace the original submission entirely and will be evaluated independently. Thus, all AoI submission requirements will remain in full force and effect.

mailto:nbr.cso.dafact@afwerx.af mailto:nbr.cso.dafact@afwerx.af mailto:NBR.cso.dafact@afwerx.af.mil 1235049968C Highlight

1235049968C Highlight

(NBR) for NITRILE MEDICAL GLOVES

c) AoI amendments requiring additional information must receive amended solutions that address the new requirements. Additional information is still subject to the AoI submission requirements (e.g. page limits, font size, etc). Failure to submit a complete solution amendment that complies with the submission requirements of the AoI may result in an incomplete solution and potential disqualification.

3) Evaluations will begin within two business days of the posting of this AOI.

4) Questions concerning this AOI can be sent to the following email:

NBR.cso.dafact@afwerx.af.mil

*Companies are advised that any Prototype Other Transaction Agreement (OTA) awarded in response to this Area of Interest may result in the award of a follow-on production contract or transaction will be available for use by one or more organizations in the Department of Defense and, as a result, the magnitude of the follow-on production contract or agreement could be significantly larger than that of the prototype OTA. As such, any Prototype Other Transaction Agreement will include the following statement relative to the potential for follow-on production: "In accordance with 10 U.S.C. 2371b(f), and upon a determination that the prototype project for this transaction has been successfully completed, this competitively awarded prototype OTA may result in the award of a follow-on production contract or transaction without the use of competitive procedures.

mailto:nbr.cso.dafact@afwerx.af mailto:nbr.cso.dafact@afwerx.af 1235049968C Highlight