AoI-0002_FA811921SC001-GLOVE INDUSTRIAL BASE EXPANSION.pdf

AoI-0002 FA811921SC001

GLOVE INDUSTRIAL BASE EXPANSION

GENERAL INFORMATION

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, produce glove making material and produce glove-manufacturing machines. The intent of this AoI is to understand the industry’s ability to increase domestic manufacturing capacity. The country’s ability to increase domestic manufacturing capacity to 1 billion gloves per month is critical to not only respond to the pandemic but also to ensure the security of glove manufacturing within the US.

The Department of Defense Joint Rapid Acquisition Cell (JRAC), Defense Assisted Acquisition (DA2) team and Department of the Air Force’s Acquisition COVID-19 Task Force (DAF ACT) need to understand industry’s ability to increase domestic manufacturing of non-sterile, powder-free, patient examination gloves, acryloNitrile Butadiene Rubber (NBR) raw glove manufacturing material and/or production of glove manufacturing equipment.

2. AoI Expansion Request

This AoI solicits solution briefs to support Health and Human Services Assistant Secretary for

Preparedness and Response (HHS/ASPR) priorities for meeting public health/pandemic needs to expand domestic production capacity of glove manufacturing within the next 6-24 month. Offerors can respond to any or all sections 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 non-sterile, powder-free, patient examination gloves, the associated raw materials and/or equipment to produce gloves.

a. Domestic Non-Sterile, Powder-Free, Patient Examination Gloves Production - Medical gloves are defined by the Food and Drug Administration (FDA) as examples of personal protective equipment that are used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations. Medical gloves are one part of an infection-control strategy. Medical gloves are disposable and include examination gloves, surgical gloves, and medical gloves). These gloves are regulated by the FDA as Class I reserved medical devices that require a

510(k) premarket notification. FDA reviews these devices to ensure that performance criteria such as leak resistance, tear resistance and biocompatibility are met.

i. What would be required for your company to increase domestic production of non-sterile, powder-free, patient examination gloves?

1. Provide a list of your company’s current glove manufacturing production capacity (Table 1 – sample table).

Table 1 Sample list of current glove capacity

LOCATION

# LINES

# GLOVES/MONTH

2. Provide a list of your company’s ability to expand capacity of non-sterile, powder-free, patient examination gloves in the US. An example format is shown in Table 2. The timeline to initial glove production should take into consideration FDA Class I 510(k) certification, completion of applicable permits, equipment purchases and installation, facility set up (utilities, water treatment, testing etc.).

Table 2- Sample List of Production Data Requested

LINES

# GLOVES

(M)/MONTH

COST FOR

FACILITY

COST

TOTAL

TIMELINE FROM

CONTRACT AWARD

(MONTHS)

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

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

5. Estimate the change in market cost of gloves as a result of this investment in increased production capacity.

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

7. Provide an estimate of sustainment plans/expectations for this domestic capability.

8. Describe plans to remain commercially viable without continual government demand or investment.

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

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

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

12. 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.

13. 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 gloves.

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 may be disqualified.

14. This solicitation is not intended for glove distributors or resellers, but is focused solely on manufacturing capacity.

15. If you are purchasing equipment/machines from a foreign source please provide information of the source and timelines of purchase to machine set up. Additionally, provide information on domestic alternatives considered and rationale to leverage a foreign vs. domestic source.

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?

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

17. Please provide as much information as possible and that is the information is thorough and accurate since this is the only information being evaluated moving forward in the CSO Process. You will be competing with other offerors for the glove industrial base expansion.

b. Domestic Production of Raw Glove Material – NBR may be a necessary ingredient in manufacturing Nitrile Gloves. This section is focused on growing industrial capability to produce

NBR within the US.

i. What would be required for your company to increase domestic production of NBR?

1. Provide a list of your company’s current NBR production capacity of glove material (Table 3 -sample) if applicable.

Table 3 Sample list of current NBR material capacity

QUANTITY

(GALLONS)/YEAR

GLOVE

EQUIVALENT/YEAR

2. Provide a list of proposed material manufacturing information to be increased domestically. An example format is shown in Table 4. The timeline to initial material production should take into consideration completion of applicable permits, equipment purchases and installation, facility set up

(utilities, water treatment, testing etc.).

Table 4 Sample List of NBR Production Data Requested

FULL

PRODUCTION

DATE

QUANTITY

(GALLONS/YEAR)

GLOVE

EQUIVALENT/YEAR

TOTAL COST

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

5. Estimate the change in market cost as a result of this investment in increased material capacity.

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

7. Provide an estimate of sustainment plans/expectations for this domestic capability.

8. Describe plans to remain commercially viable without continual government demand or investment.

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

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

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

12. 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.

13. 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.

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

15. 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.

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

17. Please ensure that you provide as much information you can and that it is thorough and accurate since this is the only information being evaluated moving forward in the CSO Process. You will be competing with other offerors for the NBR material industrial base expansion.

c. Domestic Production of Glove Manufacturing Equipment – With growing interest in domestic glove manufacturing, there is also interest in growing the industrial base of the equipment needed to manufacture gloves. This section is focused on growing industrial capability to produce glove manufacturing equipment within the US.

i. What would be required for your company to increase domestic production of equipment needed to produce non-sterile, powder-free, patient examination gloves in the US?

1. Provide a list of your company’s current production capacity of glove-manufacturing equipment

(Table 5 - sample).

Table 5 - Sample list of current Manufacturing Equipment Production

MANUFACTURING

TYPE

(HIGH SPEED OR

TRADITIONAL)

DESCRIPTION

CAPACITY

2. Provide a list of proposed domestic glove production equipment capacity. An example format is shown in Table 6. The timeline to initial material production should take into consideration completion of applicable permits, equipment purchases and installation, facility set up (utilities, water treatment, testing etc.).

Table 6 - Sample List of Equipment Production Data Requested

EQUIPMENT

CAPACITY

FACILITY

TOTAL

TIMELINE

FROM

CONTRACT

AWARD

(MONTHS)

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

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

6. Provide an estimate of sustainment plans/expectations for this domestic capability.

7. Describe plans to remain commercially viable without continual government demand or investment.

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

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

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

11. 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.

12. 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 equipment. 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.

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

14. 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.

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

16. Please ensure that you provide as much information you can and that it is thorough and accurate since this is the only information being evaluated moving forward in the CSO Process. You will be competing with other offerors for the equipment industrial base expansion.

3. SPIRAL 1 through 3– Submission Requirements

a. All guidance governing the content and evaluation criteria for required submission can be found the below at the following link: DAF ACT CSO COVID 19 Response

b. Solutions briefs for this Area of Interest shall be submitted at the email below:

gloves.cso.dafact@afwerx.af.mil https://beta.sam.gov/opp/a3c11d3423c045f383ef1f0f7628610b/view mailto:gloves.cso.dafact@afwerx.af.mil

c. 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.

4 . AoI Open Period

a. Solution Briefs may be submitted immediately upon reviewing this AoI. Solutions Briefs will be accepted until 12:00PM EDT; 30 Nov 2020.

b. Evaluations will begin within 48 hours of the posting of this AoI.

Questions concerning this AoI can be sent to the following email: gloves.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 without the use of competitive procedures. The follow-on production contact 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:gloves.cso.dafact@afwerx.af.mil