Domestic back-up manufacturing network

Title III of the Public Health Service Act is amended by inserting after section 319F–4 of such Act (42 U.S.C. 247d–6e) the following:

319F–5.

Domestic back-up manufacturing network

(a)

In general

The Secretary, acting through the Assistant Secretary for Preparedness and Response (referred to in this section as the Assistant Secretary), shall develop and maintain a network of manufacturers—(1)whose manufacturing facilities are in the United States (including small business concerns, as defined in section 3 of the Small Business Act);(2)who manufacture certain items identified by the Assistant Secretary, which shall primarily be medical supplies or supplies needed to facilitate emergency or medical response; and(3)that have voluntarily opted in for inclusion in such network, in order to provide for the domestic manufacture of necessary supplies during times of emergency or disruption of the usual supply chain. (b)

Distribution of network

The Assistant Secretary shall make information about the network described in subsection (a) available to States, local governmental entities, Indian Tribes, Tribal organizations, and urban Indian organizations, medical suppliers, hospitals, and other health care providers, as the Assistant Secretary determines appropriate, when critical supply shortfalls are anticipated.(c)

Plans developed in conjunction with participating manufacturers

Domestic manufacturers opting to participate as described in subsection (a) shall develop, in coordination with the Assistant Secretary, a comprehensive plan that identifies—(1)the items that the manufacturer could produce, which may include—(A)items such manufacturer has current capacity to produce, or the ability to rapidly expand capacity to produce; and(B)information about the manufacturer's general capacity and equipment and willingness to work with the Assistant Secretary to identify other products likely to be needed during an emergency that fit within the manufacturer's operational capabilities;(2)manufacturing capacity, including options for partial operations and full capacity operations, and the time needed to switch from standard product manufacturing to the needed emergency supply;(3)technical assistance needed for production of items needed during times of emergency, such as equipment, staff training, and regulatory compliance, including scope, duration, and the appropriate Federal agency to provide assistance; and(4)the frequency of testing by the manufacturer to ensure that the plan is operational and meets quality metrics and other obligations under Federal purchasing contracts (including with respect to contracts for supplies for the Strategic National Stockpile under section 319F–2) or to meet other requirements determined by the Assistant Secretary.(d)

Guidance

The Secretary shall issue guidance on the quality standards for items identified by the Assistant Secretary as described in subsection (a)(2), by product type or category, that apply with respect to such items produced by manufacturers included in the network.(e)

Coordination with other agencies

The Secretary shall coordinate with other Federal agencies to provide contracting opportunities for Federal purchasing of items identified by the Assistant Secretary as described in subsection (a)(2), as such items are needed, provided that such items meet all quality standards and other requirements and are produced as part of an agreement with the Federal Government. (f)

Limits on participation; opportunities for consideration

(1)

Limits

The Secretary may limit the number of manufacturers that have active manufacturing plans under subsection (c) and manufacturers that are active participants in the network described in subsection (a), taking into account diversity of product and geography of production facilities. (2)

Opportunities for future consideration

All manufacturers wishing to participate in such network shall have access to a point of contact within the Office of the Assistant Secretary for Preparedness and Response and, if not included in such network, shall have the option to add their name to a simplified list for future consideration for such participation, unless the Assistant Secretary determines there to be any substantial cause for removal of the manufacturer from such list.