Biotech in the FY27 Appropriations Process

Overview

The FY27 Appropriations process is producing a number of provisions that reflect the recommendations of the NSCEB and advance the role of biotechnology within the federal government. Each bill includes two parts, bill text and report language. Bill text moves through the legislative process, while report language is given the weight of law once the bill passes out of committee. As new appropriations legislation is passed, those provisions are captured below.

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies

House Appropriations (H.R. 8646)

Full Committee

Bill language:

Title VI, page 72. Appropriate $10 million to the Center for Drug Evaluation and Research for pilots to increase unannounced foreign inspections.

Sec. 739. Directs the Secretary of Agriculture to be included as a member of the Committee on Foreign Investment in the United States (CFIUS) on cases related to agricultural land, agriculture biotechnology, or the agriculture industry.

Sec. 744. Authorizes the Secretary of Agriculture to make grants for biotechnology risk assessment research.

Report language:

Page 7: DirectsUSDA, in coordination with EPA and FDA, to submit a report that develops a framework for regulating biotechnology products as platforms and reviews the use of “regulatory sandboxes” and short-term pilots for new regulatory pathways. For the framework, USDA, EPA, and FDA can move towards interoperable data management systems and standardized applications.
Page86: Encourages FDA to continue advancing regulatory and manufacturing pathways for genetically modified cell-based therapies. Urges FDA to identify opportunities to increase predictability and efficiencies for the Investigational New Drug application process.
Page91: Encourages the FDA to use AI to streamline its review and approval process. 
Page92: Encourages the FDA to improve staff retention and hiring.
Page 98: Recognizes the importance of U.S. participation in international standards setting bodies for biotechnology, especially in the face of China’s increasing participation, and encourages the FDA to continue being a leader in these bodies. 
Page100: Supports FDA initiatives to use New Approach Methodologies (NAMs) to support safety and efficacy testing of human pharmaceuticals.
Page 107: Directs the FDA to review, update, and streamline its Investigational New Drug submission guidance; to develop and implement a pilot program for Australian-like clinical trial notification system; and to expand opportunities for engagement with biotechnology start-ups. 
Clinical Trial Data from Foreign Adversaries. Prohibits the FDA from accepting, reviewing, or considering any covered clinical data generated by a clinical investigation site locatedin a covered nation in support of an investigational new drug application, starting one year after the enactment of the bill.
Biobased Markets Program. Directs USDA to prioritize available resources to accelerate product certification and audits under the BioPreferredprogram, expand designated product categories, strengthen Federal procurement compliance, and improve access for small and mid-sized domestic manufacturers.

National Security, Department of State, and Related Programs

House Appropriations (H.R. 8495)

Full Committee

Bill language:

Sec. 7043. Restricts the use of Department of State funds to support or promote biotechnology developed by the People’s Republic of China.

Report language:

Page 12: Encourages the Secretary of State to develop data sharing agreements with allied countries, which may include reciprocal biological data sharing; standards for high-quality, AI-ready biological data; and a determination of the consensual collection, secure storage, and ethical use of biological data standards. Recommendsthat the Secretary of State designate a senior official to lead and coordinate biotechnology.
Page 81: Directs the Secretary of State to submita report on the effectiveness of and recommendations to improve existing multilateral export control regimes, with particular focus on biotechnology.

Commerce, Justice, Science, and Related Agencies

House Appropriations (H.R.8845)

Full Committee

Bill language:

None

Report language:

Page 18: Provides up to $6 million to NIST to develop and validate technical standards and best practices for the biosecurity screening of synthetic nucleic acid, and directs Commerce to brief the committee on the status of screening adoption and any gaps in existing legislative or administrative authority that hinder the Department’s ability to ensure universal screening compliance, as well as recommendations for potential frameworks to provide the Department with the necessary oversight and enforcement mechanisms to secure the domestic bioeconomy.
Page 18: Encourages NIST to expand U.S. leadership in the development of international norms and standards for biotechnology that reflect shared values and interests with allies and partners, and supports coordinated interagency efforts on global biotechnology standards.
Page 19: Provides $5 million to equip NIST partners to develop reference materials, validated methods, and bioprocess measurement tools for plant-based, fermentation derived, and other cultivated protein products.
Page 90: Directs OSTP to provide a report within 120 days on the necessary resources needed to establish a National Biotechnology Initiative at the Executive Office of the President.
Page 103: Encourages NASA to coordinate biotechnology efforts across Mission Directorates.

Energy and Water Development and Related Agencies

House Appropriations

Full Committee

Bill language:

None

Report language:

Page 114: Directs the Department of Energy to support research and development activities that would expand, improve, and create bioindustrial scale-up user facilities; to develop standard operating procedures and educational resources, upgrade equipment and infrastructure; and support collaborations with academia and industry to accelerate biotechnology commercialization efforts.
Page 114: The recommendation provides not less than $30,000,000 for feedstock technologies research and the Biomass Feedstock National User Facility (BFNUF) and $30,000,000 for algae-related activities.
Page 147: The Committee directs the Department to provide not later than 180 days after the date of enactment of this Act a briefing regarding whether it is more effective and efficient to leverage existing plant transformation facilities by establishing a networked plant transformation capability or to construct a new centralized facility to achieve the Nation’s biotechnology goals.

Interior, Environment, and Related Agencies

House Appropriations

Full Committee

Bill language:

None

Report language:

Page 29: Directs the National Park Service to provide a briefing related to biological data and its research activities of plant and animal species, as well as opportunities to advance such work, within National Park Service units.
Page 81: Encourages the Forest Service to consider collaborative research to promote biocarbon manufacturing from forest residues for applications as forest soil amendment to increase forest productivity and enhance rural community resilience in the Southeast.
Page 98: Encourages the Smithsonian Institution to provide a briefing on the funding requirements associated with initiating a new pilot program, in partnership with the Department of the Interior, to help establish best practices for storing and managing biological samples collected under an initiative to sequence public lands, ensuring that genomic data from animals, plants, fungi, and microbes in national parks and other public lands are preserved, standardized, and made accessible for research, innovation, and education.

Financial Services and General Government

House Appropriations

Full Committee

Bill language:

None

Report language:

Page 30: Recognizes the importance of interagency coordination on biotechnology and directs the Office of Management and Budget (OMB) to submit a report on crosscut budget amounts of federal biotechnology spending across the interagency and regulatory overlap, gaps, and ambiguities related to biotechnology product regulation.

Labor, Health and Human Services, Education, and Related Agencies

House Appropriations

Full Committee

Bill language:

None

Report language:

Page 138: Encourages NIH to assess the feasibility of using publicly available research tools, such as a platform, to link federated, AI-ready biomedical datasets and AI foundation models trained on such data to advance biomedical research.
Page 140: Awareness of legislative efforts to establish a pilot program to collect new genomic data from samples found on certain public lands to contribute to scientific innovation.
Page 150: Encourages the Advanced Research Projects Agency for Health (ARPA-H) to incorporate microgravity-enabled biotechnology research and development into its project portfolio and to coordinate with relevant federal partners to maximize the return on prior investment.
Page 193: Encourages the Department of Health and Human Services (HHS) to publish a report identifying drugs reimbursed under Medicare or Medicaid whose pivotal clinical trials were conducted at People’s Liberation Army (PLA) military hospitals, Academy of Military Medical Sciences-affiliated (AMMS) sites, or sites located in the Xinjiang Uyghur Autonomous Region.
Page 219: Urges HHS, in coordination with DOD, to jointly implement a plan to onshore the end-to-end supply chain for the biomanufacturing of fermentation-based essential antibiotics to ensure necessary domestic manufacturing capacity.
Page 220: Encourages ASPR, in coordination with DOD, to provide technical expertise to FDA’s Center for Biologics Evaluation and Research, as they further the development of medical countermeasures for combatting emerging pathogens.
Page 224: Encourages prioritization of investments in next-generation blood products based on clinical readiness and directs HHS to brief on the progress of these efforts.
Page 228: Directs ASPR, in coordination with other appropriate federal partners, to assess whether current medical countermeasures stockpiling levels adequately account for risks associated with synthetic biology and AI-enabled biological threats.
Page 236: Directs FDA to brief on current agency policies and practices regarding the use of single-arm trials and other flexible clinical trial designs in accelerated approval applications for treatments targeting serious or life-threatening diseases.
Page 238: Encourages HHS to promote robust disclosures of whether pivotal clinical trials were conducted at PLA military hospitals or locations in Xinjiang, so that policymakers and program administrators can better assess related risks.
Page 245: Encourages HHS to develop a framework to strengthen interagency coordination for rare diseases, including but not limited to regulatory flexibilities in rare disease therapy reviews, current and emerging biomedical research opportunities, current and future rare disease surveillance and epidemiological activities, and analysis and outcomes using federal program data, as well as programs to support rare disease patients and caregivers, and overall programmatic funding.