Activities related to promoting competitiveness in biomanufacturing in the United States

(a)

In general

Not later than 1 year after the date of the enactment of this Act, the Secretary shall designate a senior official to— (1)lead the activities of the Department of Commerce relating to biomanufacturing and biomanufactured products in the United States; (2)carry out the activities described in subsection (b); and (3)promote commercial competitiveness with respect to such biomanufacturing and biomanufactured products. (b)

Activities described

The activities described in this subsection are the following: (1)Identify the following: (A)Any Federal process, resource, or publicly available information relevant to promoting commercial competitiveness with respect to biomanufacturing and biomanufactured products in domestic and foreign commerce. (B)Any barrier to private sector investment in biomanufacturing, market adoption of biomanufactured products, or domestic production of such products, including barriers arising from unclear, duplicative, or unpredictable Federal processes related to the commercialization of such products. (C)Any vulnerability, chokepoint, supplier concentration, single point of failure, market barrier, or other constraint affecting a supply chain related to a critical biomanufacturing input, including any such vulnerability, chokepoint, supplier concentration, single point of failure, market barrier, or other constraint related to a foreign adversary or a foreign adversary entity. (D)Any opportunity for a private sector entity or policymaker to strengthen domestic production, supplier diversification, commercialization, and supply chain resilience related to biomanufacturing or biomanufactured products. (E)The availability of domestic production capacity, inputs, equipment, and other resources related to the commercial manufacturing of biomanufactured products in the United States, including with respect to the following: (i)Amino acids. (ii)Industrial enzymes. (iii)Microbial strains. (iv)Cell lines. (v)Cell banks. (vi)Bioreactors. (vii)Single-use bioprocessing components. (2)Facilitate consultations, on a voluntary basis, for participating non-Federal entities to promote commercial competitiveness with respect to biomanufacturing and biomanufactured products, including consultations required pursuant to subsection (d)(3). (3)Consult with the heads of relevant Federal agencies, and any relevant agency point of contact, including the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, and the Administrator of the Environmental Protection Agency, as the Secretary determines appropriate, with respect to matters affecting the competitiveness of biomanufacturing, supply-chain resilience, and the commercial manufacturing of biomanufactured products. (4)Maintain a publicly available web resource that consolidates or provides links to publicly available Federal resources relevant to the commercialization of biomanufactured products, as determined appropriate by the Secretary, including the following information and resources: (A)Any practice identified and made publicly available under subsection (d). (B)The report required under subsection (e)(1). (C)Any point of contact designated under subsection (e)(3) or otherwise made publicly available by a relevant Federal agency. (5)Serve as a point of coordination for non-Federal entities seeking publicly available information related to a Federal process identified under paragraph (1)(A), including by referring such entities to the appropriate Federal agency or point of contact. (c)

Assessment

(1)

In general

Not later than 1 year after the date of the enactment of this Act, and every 2 years thereafter, the Secretary, acting through the senior official designated pursuant to subsection (a), shall conduct an assessment with respect to the following: (A)The current and, to the extent practicable, reasonably foreseeable future availability of critical biomanufacturing inputs and domestic production capacity related to biomanufacturing in the United States. (B)The extent to which private sector entities in the United States rely on foreign adversaries or foreign adversary entities for critical biomanufacturing inputs or production capacity related to biomanufacturing. (C)Any vulnerability, chokepoint, single point of failure, supplier concentration, market barrier, or other constraint impacting the access of a private sector entity to critical biomanufacturing inputs or domestic production capacity related to biomanufacturing. (D)The availability of substitutes for critical biomanufacturing inputs in the United States, including from other sources that are not foreign adversaries or foreign adversary entities. (E)Estimated lead times and economic or operational barriers to reducing reliance by private sector entities on a foreign adversary or a foreign adversary entity for critical biomanufacturing inputs or production capacity related to biomanufacturing. (F)Any barrier identified under subsection (b)(1)(B), including the following: (i)Any Federal process for which a review related to commercialization is divided among multiple Federal agencies. (ii)Any barrier arising from limited access to shared pilot-scale and demonstration-scale manufacturing capacity. (G)Any opportunity for domestic producers and suppliers to expand the capacity of, improve the reliability of, and diversify supply chains for critical biomanufacturing inputs. (H)Any impact on commerce and biomanufacturing in the United States if a vulnerability, chokepoint, single point of failure, supplier concentration, market barrier, or other constraint identified under subparagraph (C) is not addressed, including any impact on relevant domestic supply-chain resilience and access to biomanufactured products. (I)Biomanufacturing capacity located outside of the United States, including capacity at contract manufacturing facilities and company-owned facilities, and capacity owned or controlled by foreign adversaries or foreign adversary entities, to— (i)compare such biomanufacturing capacity with the biomanufacturing capacity of the United States; and (ii)assess the impact of such capacity on domestic industry. (2)

Prioritization

In conducting the assessment under paragraph (1), the Secretary, acting through the senior official designated pursuant to subsection (a), shall prioritize the matters described in such paragraph based on the following: (A)The commercial significance of the relevant affected critical biomanufacturing input or production capacity. (B)Potential consequences for commerce in the United States. (C)The extent of reliance on foreign adversaries or foreign adversary entities. (D)Estimated lead times and barriers to reducing such reliance. (E)The availability of substitute sources. (3)

Prioritized action plan

Based on each assessment under paragraph (1), the Secretary shall prepare and include in any report submitted and made publicly available under subsection (g) a prioritized action plan that— (A)ranks each supply-chain risk and commercialization barrier identified in the assessment by commercial significance and potential consequence for commerce in the United States; (B)identifies actions the Secretary may take to improve supply-chain visibility, stakeholder coordination, and access to information related to the commercialization of biomanufactured products; (C)identifies existing Federal financial assistance programs and other Federal resources that may address any such supply-chain risk or commercialization barrier; (D)identifies any program or resource described in subparagraph (C) that should be added to the web resource maintained under subsection (b)(4); and (E)identifies opportunities for the Secretary to coordinate with relevant Federal agencies and non-Federal entities to reduce such risks and barriers. (d)

Voluntary practices

(1)

In general

Not later than 1 year after the date of the enactment of this Act, and as the Secretary determines appropriate thereafter, the Secretary shall identify and make publicly available industry-led, evidence-based, or widely accepted practices related to the following: (A)The commercialization of biomanufacturing processes and biomanufactured products. (B)The readiness of biomanufacturing processes or biomanufactured products for commercial production. (C)The reliability and operational consistency of biomanufacturing processes and the quality of biomanufactured products. (D)Supplier qualification, supplier diversification, and commercial supply chain risk management for critical biomanufacturing inputs. (E)The voluntary sharing of nonproprietary information related to biomanufacturing process and the supply chains for biomanufacturing processes or biomanufactured products that is necessary to support commercialization and commercial manufacturing, including the secure and portable transfer of information that a process originator elects to share with a manufacturing partner, as appropriate. (F)The protection of trade secrets, confidential business information, and intellectual property relating to biomanufacturing. (G)The participation of small and medium-sized businesses and manufacturers in biomanufacturing. (H)The use of biomanufactured products in domestic and foreign commerce. (I)The use of digital, computational, automated, or artificial intelligence tools in commercial biomanufacturing to improve reliability, efficiency, product quality, and consistency. (2)

Existing practices

In carrying out paragraph (1), the Secretary shall— (A)prioritize identifying existing practices, including practices issued or maintained by industry-led organizations, and making such practices publicly available; and (B)avoid unnecessary duplication of such practices. (3)

Consultation

In carrying out paragraph (1), the Secretary shall consult with non-Federal entities, including the following: (A)The following private sector entities: (i)Manufacturers and suppliers of critical biomanufacturing inputs. (ii)Small and medium-sized businesses and manufacturers of biomanufactured products. (iii)Companies seeking to commercialize, produce, or use biomanufactured products. (iv)Investors, accelerators, and other entities involved in commercialization. (B)State, local, Tribal, territorial, and regional commerce or manufacturing organizations. (C)Experts in commercial supply-chain resilience, manufacturing, and competitiveness. (4)

Prioritization of United States and trusted stakeholders

In carrying out paragraph (3), the Secretary shall prioritize, to the extent practicable, input from non-Federal entities in the United States and other stakeholders that are neither foreign adversaries nor foreign adversary entities. (5)

Public input

(A)

In general

The Secretary shall provide at least 1 opportunity for the public to submit input under this subsection. (B)

Methods

The Secretary may solicit public input under this subsection through making requests for information, workshops, roundtables, meetings with non-Federal entities, or any other means the Secretary determines appropriate. (e)

Federal commercialization pathway map; agency points of contact

(1)

Report

Not later than 1 year after the date of the enactment of this Act, the Secretary, in consultation with the heads of relevant Federal agencies, shall submit to the appropriate congressional committees and make publicly available a report that identifies and maps any Federal process that may apply to the commercialization of biomanufactured products and critical biomanufacturing inputs, as the Secretary determines appropriate. (2)

Contents

The report required under paragraph (1) shall do the following: (A)Organize any Federal process identified and mapped under such paragraph by category of biomanufactured product or critical biomanufacturing input, as the Secretary determines appropriate. (B)Identify the following: (i)Any publicly available point of contact for a Federal agency and any existing public guidance related to any such Federal process. (ii)Overlaps, gaps, ambiguities, and timing or predictability concerns related to any such Federal process. (iii)Opportunities to improve the clarity and predictability of, and reduce duplication among, any such Federal process. (3)

Agency points of contact

Not later than 180 days after the date of the enactment of this Act— (A)the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall— (i)designate a point of contact to assist non-Federal entities in identifying publicly available information related to any process of the Food and Drug Administration that may apply to biomanufactured products or critical biomanufacturing inputs; and (ii)ensure such point of contact coordinates, as appropriate, with relevant components of the Food and Drug Administration in carrying out clause (i); and (B)the Administrator of the Environmental Protection Agency shall designate a point of contact to assist non-Federal entities in identifying publicly available information related to laws administered by the Administrator of the Environmental Protection Agency that may apply to biomanufactured products or critical biomanufacturing inputs. (4)

Integration with existing resources

(A)

In general

In carrying out paragraphs (1) and (2), the Secretary may incorporate or rely on a substantially similar existing Federal resource, report, assessment, map, or other activity if the Secretary determines that it substantially addresses the applicable requirement. (B)

Inclusion in report

If the Secretary incorporates or relies on a substantially similar existing Federal resource, report, assessment, map, or other activity under subparagraph (A), the Secretary shall include in the report required under paragraph (1) the following: (i)An identification of the resource, report, assessment, map, or other activity. (ii)An explanation of how the resource, report, assessment, map, or other activity addresses the applicable requirement. (5)

Updates

The Secretary shall update the report required under paragraph (1) to reflect any material change to any Federal process described in such paragraph, as the Secretary determines appropriate. (f)

Protection of information

(1)

In general

The Secretary may not publicly disclose any nonpublic information voluntarily submitted by a non-Federal entity under this section that— (A)constitutes a trade secret or confidential business information; or (B)is sensitive supply-chain vulnerability information. (2)

Exemption from disclosure

Information described in paragraph (1) shall be exempt from disclosure under section 552(b)(3) of title 5, United States Code. (3)

Identification and determination

(A)

In general

The Secretary shall establish a process for a non-Federal entity that voluntarily submits information under this section to identify whether the entity considers such information to be nonpublic information described in paragraph (1). (B)

Determination

If a non-Federal entity makes an identification under the process required by subparagraph (A), with respect to information voluntarily submitted under this section by such entity, the Secretary shall determine whether such information is nonpublic information described in paragraph (1). (C)

Treatment pending determination

The Secretary may not publicly disclose any information with respect to which a non-Federal entity makes an identification under paragraph (3)(A) unless the Secretary has determined such information is not nonpublic information described in paragraph (1). (g)

Reports

(1)

In general

Not later than 1 year after the date of the enactment of this Act, and every 2 years thereafter, the Secretary, acting through the senior official designated pursuant to subsection (a), shall submit to the appropriate congressional committees, and make publicly available on a website of the Department of Commerce, a report that includes the following: (A)A summary of any action carried out by the Secretary under this section. (B)Any assessment conducted under subsection (c). (C)Any prioritized action plan prepared under paragraph (3) of such subsection. (D)A summary of any practices identified and made publicly available under subsection (d). (E)Any updates related to the report required under subsection (e)(1). (2)

Nonpublic annex

The Secretary, acting through the senior official designated pursuant to subsection (a), may submit to the appropriate congressional committees a nonpublic annex to a report required under paragraph (1) that includes nonpublic information described in subsection (f)(1). (h)

Termination

The requirements under subsections (a) through (e) and subsection (g) shall terminate on the date that is 5 years after the date of the enactment of this Act. (i)

Definitions

In this section: (1)

Appropriate congressional committees

The term appropriate congressional committees means— (A)the Committee on Energy and Commerce of the House of Representatives; and (B)the Committee on Commerce, Science, and Transportation of the Senate. (2)

Biomanufactured product

The term biomanufactured product means a commercial good, material, chemical, protein, component, industrial input, or other product or substance in commerce that is produced, processed, purified, or transformed through biomanufacturing. (3)

Biomanufacturing

The term biomanufacturing means the use of biological systems, including cells, cell-free systems, enzymes, or biomolecules, in manufacturing processes to produce, process, or transform commercial goods, materials, chemicals, proteins, components, industrial inputs, or other products or substances in commerce. (4)

Critical biomanufacturing input

The term critical biomanufacturing input means an input, material, reagent, item of equipment, or software used in biomanufacturing that is commercially significant to biomanufacturing in the United States and subject to supply-chain risk, such as supplier concentration, reliance on a foreign adversary or foreign adversary entity, limited substitutes, or long lead times. (5)

Foreign adversary

The term foreign adversary means a foreign government or foreign non-government person identified as a foreign adversary under section 791.4 of title 15, Code of Federal Regulations, or any successor regulation. (6)

Foreign adversary entity

The term foreign adversary entity has the meaning given the term person owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary in section 791.2 of title 15, Code of Federal Regulations, or any successor regulation. (7)

Non-federal entity

The term non-Federal entity means a State, local, Tribal, or territorial government, nonprofit organization, technical organization, industry association, commerce or manufacturing organization, private sector entity, or other stakeholder. (8)

Secretary

The term Secretary means the Secretary of Commerce. (9)

Sensitive supply-chain vulnerability information

The term sensitive supply-chain vulnerability information means nonpublic information with respect to which the public disclosure of such nonpublic information could be reasonably expected to reveal a vulnerability, dependency, chokepoint, single point of failure, supplier concentration, or other weakness in a supply chain relevant to biomanufacturing in the United States.