JATF_CSO_PPE_AoI_v1.pdf

3 Aug 2020 / FA7013-20-S-0002AOI_03

UPDATE

General Information

1. Personal Protection Equipment Industrial Base Expansion Area of Interest (AoI) Background

The recent COVID-19 Public Health Emergency has illuminated the fragility of the United States’ domestic capacity to manufacture Personal Protection Equipment (PPE). The intent of this AoI is to understand the industry’s ability to produce all aspects of PPE domestically. The country’s ability to produce all aspects of PPE domestically is critical to not only responding to pandemics but also ensure the security of the nation as it relates to PPE manufacturing.

The Department of Defense Joint Acquisition Task Force (JATF) and Department of the Air Force’s Acquisition COVID-19 Task Force (DAF ACT) need to understand industry’s ability to domestically produce

a. Non-Sterile, Powder-Free, Patient Examination Gloves

b. Surgical gowns and surgical isolation gowns meeting a minimum of level 2 or higher protection

(disposable or resuable)

2. AoI Expansion Request

This AoI solicits solution briefs to meet Health and Human Services Assistant Secretary for Preparedness and Response (HHS/ASPR) priorities for meeting future public health/pandemic needs to to expand domestic production capacity of PPE manufacturing within the next 6-24 months. Offerors can respond to any or all production sections based on their resident expertise and ability to expand domestic manufacturing. The JATF would like to understand industries’ ability to expand their domestic capacity to produce Non-Sterile, Powder-Free, Patient Examination Gloves, and surgical gowns and surgical isolation gowns meeting a minimum of level 2 or higher protection (disposable or reusable), as well as the Raw Materials associated with them.

a. Domestic Non-Sterile, Powder-Free, Patient Examination Gloves Production, Medical Gloves is defined by the FDA 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 for handling chemotherapy agents (chemotherapy 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. For manufacturers of Non-Sterile, Powder-Free, Patient Examination Gloves, what would be required for your company to consider domestic production of Non-Sterile, Powder-Free, Patient Examination Gloves?

1. Provide a list of proposed Non-Sterile, Powder-Free, Patient Examination Gloves manufacturing to be shifted from overseas to domestic production and why these were selected. What is the method you used to justify and prioritize these particular facilities?

2. Provide a timeline for establishing domestic production of 250 million Non-Sterile, Powder-Free, Patient Examination Gloves annually

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

4. Provide estimates of production volumes of Non-Sterile, Powder-Free, Patient Examination Gloves

5. Estimate the cost increase per Non-Sterile, Powder-Free, Patient Examination Gloves by changing to domestic production

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

ii. If already a domestic producer, what would be required for your company to expand domestic production of Non-Sterile, Powder-Free, Patient Examination Gloves by 250 million annually?

1. Provide a list of proposed domestic Non-Sterile, Powder-Free, Patient Examination Gloves manufacturing to be expanded and why these were selected. What is the method you used to justify and prioritize these particular facilities?

2. Provide a timeline for establishing domestic production of Non-Sterile, Powder-Free, Patient Examination Gloves

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

4. Provide estimates of production volumes of Non-Sterile, Powder-Free, Patient Examination Gloves

5. Identify barriers to expanding domestic production (i.e. regulatory, legislative, policy etc)

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

7. Provide any additional relevant information for consideration by the review time

iii. What advanced manufacturing techniques would you/do you rely upon to achieve support for the Medical mask requirement?

b. Surgical Gowns and Surgical Isolation Gowns meeting a minimum of level 2 or higher protection Production, Surgical gowns is defined by the FDA as a Class II medical device that requires a 510(k) premarket notification. A surgical gown is a personal protective garment intended to be worn by health care personnel during surgical procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate matter. Because of the controlled nature of surgical procedures, critical zones of protection have been described by national standards. As referenced in Figure 1: the critical zones include the front of the body from top of shoulders to knees and the arms from the wrist cuff to above the elbow. Surgical gowns can be used for any risk level (Levels 1-4). All surgical gowns must be labeled as a surgical gown. A Surgical Isolation Gown is used when there is a medium to high risk of contamination and a need for larger critical zones than traditional surgical gowns. Surgical isolation gowns, like surgical gowns, are regulated by the FDA as a Class II medical device that will be required to meet a 510(k) premarket notification. All areas of the surgical isolation gown except bindings, cuffs, and hems are considered critical zones of protection and must meet the highest liquid barrier protection level for which the gown is rated.

All seams must have the same liquid barrier protection as the rest of the gown. Additionally, the fabric of the surgical isolation gown should cover as much of the body as is appropriate for the intended use. See below for Level 2-4 definitions:

Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab

Level 3: Moderate risk, to be used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases

Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne)

i. For Suppliers of disposable isolation and surgical gowns, what would be required for your company to consider domestic production of the gowns?

1. Provide a list of proposed disposable isolation and surgical gowns manufacturing to be shifted from overseas to domestic production and why these were selected. What is the method you used to justify and prioritize these particular facilities?

2. Provide a timeline for establishing domestic production of 1.5 million disposable isolation and surgical gowns annually

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

4. Provide estimates of production volumes of disposable isolation and surgical gowns

5. Estimate the cost increase per disposable isolation and surgical gowns by changing to domestic production

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

ii. If already a domestic producer, what would be required for your company to expand domestic production of disposable isolation and surgical gowns?

1. Provide a list of proposed domestic disposable isolation and surgical gowns manufacturing to be expanded and why these were selected. What is the method you used to justify and prioritize these particular facilities?

2. Provide a timeline for establishing domestic production of 1.5 million disposable isolation and surgical gowns annually

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

4. Provide estimates of production volumes of disposable isolation and surgical gowns

5. Identify barriers to expanding domestic production (i.e. regulatory, legislative, policy etc)

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

7. Provide any additional relevant information for consideration by the review time

8. What advanced manufacturing techniques would you/do you rely upon to achieve support for the disposable isolation and surgical gowns?

iii. Additional inputs:

1. Please include any additional issues/considerations related to the domestic production of PPE not included in the previous questions

3. SPIRAL 1 through 3– Submission Requirements

1. 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 JATF CSO link:

https://beta.sam.gov/opp/11fe0354f7bd4330aa147b64c1082f81/view?keywords=%22jatf_cso_ covid_19%20response%22&sort=-relevance&index=&is_active=true&page=1

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

JATFCSO_AOI_GLOVESGOWNS@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.

2. AoI Open Period

a. Solution Briefs may be submitted immediately upon reviewing this AOI. Solutions Briefs will be accepted until 5:00PM CST; 7 Aug 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:

JATFCSO_AOI_GLOVESGOWNS@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.

https://beta.sam.gov/opp/11fe0354f7bd4330aa147b64c1082f81/view?keywords=%22jatf_cso_covid_19%20response%22&sort=-relevance&index=&is_active=true&page=1 https://beta.sam.gov/opp/11fe0354f7bd4330aa147b64c1082f81/view?keywords=%22jatf_cso_covid_19%20response%22&sort=-relevance&index=&is_active=true&page=1