STATEMENT OF OBJECTIVES (SOO)

N95 Respirator -
Production Capacity Preservation

1.0 SCOPE
This Statement of Objectives (SOO) is to assure the production preservation capacity of
National Institute for Occupational Safety and Health (NIOSH)-approved N95 respirators
domestically in the United States. This investment is designed to ensure that domestic
production is available during a time of need such as a public health emergency.

2.0 BACKGROUND
During the COVID-19 health emergency, the Department of Health and Human Services (DHHS)
made substantial investments in the domestic production of N95 respirators. To protect this
domestic production, DHHS seeks to preserve these capacities to maintain a warm supply chain of
N95 respirators for both current and future health emergencies. DHHS plans to use a multifaceted
approach with multiple domestic manufacturers to ensure this supply chain is sustainable long
term and can meet demands during public health emergencies.

The Strategic National Stockpile (SNS) will maintain sufficient N95 respirators in stock to
compliment this warm reserve manufacturing capability described above and will serve as a
bridge to support immediate requirements while the warm manufacturing capabilities are ramping
up to population scale demands when required. The key to national support is having available,
agile, and sustained N95 respirator manufacturing capacity. N95 respirator availability affects the
ability of laboratory, medical, and other critical infrastructure workers to safely perform their
duties. Laboratory, medical, and other critical infrastructure workers are required to wear personal
protective equipment (PPE) to help protect themselves from exposure to airborne hazards during
the collection and testing of clinical specimens. Without this investment, N95 respirator domestic
manufacturing capabilities will continue to constrict, leading to reliance on overseas capabilities,
delaying support to our laboratory, medical, and other critical infrastructure workers, and
ultimately affecting national security.

3.0 OBJECTIVES
The Offeror shall propose a Statement of Work and technical proposal to address the objectives
in Sections 3.1-3.3.

3.1 Technical Requirements –

3.1.1 The manufacturers will provide a strategic business plan that identifies required
funding needed to address how the company will be ready to achieve the
anticipated maximum N95 demand if, when, the United States Government (USG)
determines need. The plan will include: (1) the manufacturers maximum
production capacity to manufacture NIOSH-approved, surgical and/or non-surgical
N95 respirators per month, (2) the schedule and associated timeline to rapidly
expand respirator production and reach full production capacity within 90 or 120
days upon request, (3) the warehousing and stocking of necessary raw materials
 from supplier approved sources, (4) how production lines/machines will be cycled
to ensure they are validated and in good working order along with the required
regulatory compliance, (5) how they will guarantee and maintain their supply chain
functionality and responsibilities through contracts, and (6) how they will train and
staff for full manufacturing capacity should the need arise to ramp to maximum
manufacturing production capacity over the next 10 years.
3.1.2 The business plan shall contain the following:
• Requirements to sustain production machines to include serviceability,
maintenance, and quality systems requirements for the period of
performance. The manufacturer should propose at what percentage of
production capacity it can operate N95 respirator production lines to
sustain them during low demand or nonemergency periods.
• Retention of critical workforce skill sets needed to rapidly execute a surge
in production within 60 days, to reach full capacity within 120 days
(optimal 90 days) of government direction.
• The manufacturer shall possess and maintain validated and FDA audited
production capability to manufacture up to (the contractor’s maximum
capacity as per 3.1.1 (1)) NIOSH-approved, surgical and/or non-surgical
N95 respirators per month. The USG is not specifying a particular model
of N95 respirator nor is the USG specifying surgical/non-surgical N95
respirators, only that the N95 respirators are suitable for use in medical
settings.
• Manufacturers’ recommendations to maintain the capacity to produce N95
respirators at their maximum monthly production rate within 90 or 120
days of USG notification and provide options to operate N95 respirator
production lines at lower volume during low demand or non-medical
emergency periods.
• The USG requires priority access to N95 respirator stocks and production
capacity for a period of 10 years.
• Manufacturers shall provide evidence of commercial viability. It is the
USG’s goal to ensure that manufacturers are not wholly dependent upon
USG investment, intervention or N95 respirator production only.
3.1.3 The USG expects this monthly level of production to be executable no more than
90 or 120 days after notification by the PCO.
3.1.4 This effort is not intended for the procurement of any end items; this would be
executed in a separate contractual effort.

3.2 Period of Performance

3.2.1. 36 Months after Contract Award.

3.3 Program Management, Administration, and Reporting Requirements

3.3.1. The Offeror shall provide the overall program management functions required to
execute this SOO for the duration of the contract. A designated Program Manager
shall lead the day-to-day management of program activities required to meet
delivery schedules defined in the contract.
3.3.2. The Offeror shall propose how they will identify and actively manage project risks, to
 include, but not limited to, supply chain risks.
3.3.3. The Offeror shall notify the Government, as soon as possible, where it may be able to
assist in risk mitigation.
3.3.4. The Offeror shall identify technology improvements to machinery, when available or
as needed, to the government to determine possible investment opportunities to
improve capacity and capability.
3.3.5. The Offeror shall insure, maintain, operate, validate, and service all equipment
and tooling acquired by the Offeror funded by this award as required to produce
NIOSH-approved N95 Respirators.
3.3.6. The Offeror shall implement and maintain the proper current good-
manufacturing practices (cGMP) and quality management systems, to the extent
applicable.
3.3.7. The Offeror shall propose a workforce management plan, e.g., how workforce
will train, maintain, etc., that reflects the ability to meet the Statement of
Objectives.
3.3.8. The Offeror shall manage, including flow-down requirements, partnerships,
subcontractors, or other business arrangements needed to complete expanded
production and qualification of the tool/equipment to be produced.
3.3.9. The Offeror shall provide a monthly production progress report that
addresses all of the above and includes the monthly production numbers, as
well as immediate updates for any impediments technical or otherwise that
could adversely affect the performance schedule.
3.3.10. The Offeror shall revalidate the business plan on at least an annual basis and
may refine the plan, pending government approval, based on a change in the
pandemic requirement, newer/improved NIOSH approved model, etc.

4.0 Deliverables:
The contractor shall develop and deliver a Statement of Work and technical and price proposal
(includes prices, if different, for 90 and 120 days) for the efforts described in this SOO.